CN106902405A - 用于将抗微生物剂递送到经皮导管中的装置 - Google Patents
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Abstract
用于将一种抗微生物剂递送到经皮导管的内腔中的一种系统、方法及物品。在一个实施例中,该系统包括一个被配置成插入到导管的内腔中的长形构件,并且该长形构件含有抗微生物剂。在替代方案中,可以将一种抗微生物剂放置在一个保持环的内表面上。
Description
本申请是以对于除了美国之外所有国家指定的Pursuit Vascular公司(一个美国国营公司)、以及仅对于美国指定的申请人罗伯特J.Ziebol(—位美国公民)和基思J.Modert(一位美国公民)的名义作为一个PCT国际专利申请于2012年7月12日提交的,并且要求于2011年7月12日提交的美国临时专利申请序列号61/506,979的优先权,其内容通过引用结合在此。
技术领域
本发明涉及用于防止感染性生物进入并占据导管和引流管的内腔的医疗装置,并且更具体地涉及用于将抗微生物剂递送到导管和引流管的内腔中并靠近入口区域的(在近端)的系统、方法及物品。
背景技术
血液透析导管允许患有肾脏疾病的患者从他们的血流中去除毒素。如果不使用导管,这些患者中许多人都不能存活。然而,长期血液透析导管有一个严重的缺点在于,相当大比例的导管由于感染而失效,导致死亡率升高以及与治疗相关的巨大年度医疗保健费用。此外,在美国血流感染是主要死亡原因,并且其中许多感染可归因于血管通路装置,例如血液透析导管。与这样的感染相关的死亡率是相当可观的。
因此,对于其中可以降低与长期血液透析导管相关的感染的方式存在着需要。
发明内容
本申请在某种程度上涉及一种用于将抗微生物剂递送到经皮导管的内腔中的装置。该装置包括一个被配置成插入到导管近端中的长形构件以及一种被定位成有待递送到该导管中的抗微生物组合物。在将长形构件插入到导管的近端时,至少一部分抗微生物组合物被递送到导管的近端的外部。
本申请还涉及一种用于将抗微生物剂递送到经皮导管的内腔中的装置,该装置包括一个被配置成放置在导管近端上的加帽构件;以及一种被定位在该加帽构件的内部上的抗微生物组合物。
本申请还涉及一种将抗微生物剂施用到经皮导管的近端的方法。该方法包括提供一个经皮导管;用锁定溶液填充该经皮导管的近端的至少一部分;将经皮导管在靠近其近端处夹紧以限制锁定溶液的流动到该经皮导管的远端中;并将一个长形构件插入该经皮导管的近端,这样使得该长形构件使锁定溶液充分移位,以便使锁定溶液从导管的近端流动。该长形构件包括或结合一种抗微生物材料。
本概述并不旨在限制本发明。将在以下详细说明以及权利要求书中进一步描述本发明。
附图说明
结合以下附图可以更全面地理解本发明,其中:
图1A是一个根据本发明的优选实现方式制造的具有两个帽的双罩的透视图。一个帽被插入到该双罩中;另一个帽没有插入。
图1B是被插入到一个双罩中的两个帽的侧截面图,并且是根据本发明的优选实现方式制造的。
图2A是一个根据本发明的实现方式制造的长形构件以及单罩的透视图。显示该帽没有被插入到该单罩中。
图2B是一个被插入到根据本发明的实现方式制造的单罩中的一个帽的侧截面图。
图3A是一个根据本发明的优选实现方式制造的从帽的远端来看的透视图。
图3B是一个根据本发明的优选实现方式制造的一个帽的侧截面图。
图4A是根据本发明的优选实现方式制造的两个帽以及一个导管的透视图。显示这些帽没有被插入到该导管中。
图4B是一个根据本发明的优选实现方式制造的并插入到导管中的一个帽的侧截面图。
图4C是一个根据本发明的优选实现方式制造的并插入到导管中的一个帽的端截面图。
图5A是一个根据本发明的优选实现方式制造的在将帽插入到导管之前的一个帽的侧截面图。
图5B是一个根据本发明的优选实现方式制造的在将帽插入到导管之前的一个帽的侧截面图。
图5C是一个根据本发明的优选实现方式制造的一个帽的侧截面图,其中该帽被完全插入到导管中。
图6是一个根据本发明的一个实现方式制造的在保持环的远端具有密封件的一个帽的侧截面图,该帽被插入到导管中。
图7是一个根据本发明的一个实现方式制造的沿着保持环的螺纹具有泡沫的一个帽的侧截面图,该帽被插入到导管中。
图8A是一个根据本发明的一个实现方式制造的具有可膨胀尖端的帽的侧截面图,该帽被插入到导管中。该尖端是以其未膨胀状态显示的。
图8B是一个根据本发明的一个实现方式制造的具有可膨胀尖端的帽的侧截面图,该帽被插入到导管中。该尖端是以其膨胀状态显示的。
图9是根据本发明的一个实现方式制造的不包含长形构件的帽的侧截面图。
图10A是一个根据本发明的一个优选实现方式制造的从帽的远端来看的透视图。
图10B是一个根据本发明的一个优选实现方式制造的从一个插入件的远端来看的透视图。
图10C是一个根据本发明的一个优选实现方式制造的从一个插入件的近端来看的透视图。
图10D是一个根据本发明的一个优选实现方式制造的从一个保持环的远端来看的透视图。
图10E是一个根据本发明的一个优选实现方式制造的一个保持环的侧截面图。
图10F是一个根据本发明的一个优选实现方式制造的一个帽的侧截面图。
图11是一个表,显示了在保持环与肩台之间的过盈对环-插入件扭矩的影响。
图12显示了不同导管条件下生长的微生物的浓度。
图13显示了一个在各种条件下的无菌导管的存活分析图。
具体实施方式
本发明涉及用于治疗、防止并消除医疗装置(如导管和引流管)中的感染性生物并防止微生物进入血流的装置、系统、以及方法。这些装置、系统及方法将抗微生物剂递送到导管和引流管的内腔中并靠近入口区域。以下详细说明呈现了某些具体实施例的说明以帮助理解权利要求书。然而,人们可以如权利要求书所定义和涵盖的众多不同的实施例来实施本发明。
在某些实现方式中本发明包括用于防止在导管中生物增殖和生物膜形成的方法和装置,这样使得生物不能离开导管并进入患者的血流中。该装置和系统通过采用以下三种防止方法中的任何一种或全部防止或减少了到达血液的生物的数量:1)物理阻断生物迁移到导管外,2)沿着螺纹、端面及鲁尔连接器在导管的近端(身体的外部)使用一种抗微生物剂来杀死生物,和/或3)在导管的限制区域内使用一种抗微生物剂和/或在导管内腔中的一种物理屏障来杀死生物。第四种作用方式,擦洗导管壁(以便在将帽从导管中移除时将附着在导管的近端(螺纹和/或端面)和/或内壁部分的生物物理去除)还可在某些实现方式中与其他方法和装置结合使用或独立使用。在第一方面,本发明包括在该导管的外端(在此也被称为该导管的近端)的一种生物屏障。这种屏障提供了一种阻止生物到达该端面以及在导管上的连接器的鲁尔接头部分的密封件。这可以例如通过使用以下部件的任何一种来实现:首先,放置一个弹性体翼片或垫圈(即,硅酮、氯丁橡胶、聚氨酯等等),将其定位在帽连接器的末端,或者可替代地沿着帽锁定环的内壁定位。该翼片优选地在导管连接器的外壁上产生一种流体紧密密封,从而减少微生物侵入的可能性并防止微生物生长。第二,沿着帽的保持环和/或在帽中的最近端处放置泡沫,优选含有抗微生物剂的闭孔或开孔泡沫,这样泡沫将邻接并抵靠密封在导管的连接器表面(也称为端面)的近端。
沿着帽的梯面(tread)区域使用抗微生物剂但不含有生物屏障的一个实施例还可以被用来减少可能进入导管的生物的数量。通过杀死在梯面和端面区域内的生物来实现这种可能进入导管的生物的数量的减少。该帽任选地被设计为将抗微生物剂从帽转移到导管螺纹。这是通过将流体从导管移位到连接器的螺纹区域来实现的。当该长形构件和鲁尔接头进入导管时使导管的流体移位,引起流体流出到在连接器与帽之间的螺纹区域中。
抗微生物剂溶解在流体中,引起该流体变得被抗微生物剂饱和。抗微生物流体产生一个有效的杀菌区域,从而杀死在连接器上的生物。此外,随着流体干燥,抗微生物剂从流体中沉淀并沉积在导管螺纹和端面上。重复这个过程,每次将一个新的帽放置在导管上,从而用每个新的帽来补充导管近端区域上的抗微生物剂。
在第二方面,本发明涉及沿着一个鲁尔连接器来添加抗微生物剂。这可以例如通过用各种抗微生物剂涂覆公鲁尔连接器来实现。
在第三方面,本发明涉及一种在导管内的抗微生物剂。该抗微生物剂可以作为一种被涂覆在长形构件上(或浸透在其中)的从被涂覆的长形构件上洗脱出的涂料而被递送(例如沿着一个长17mm x直径1.9mm的长形构件/杆的一个厚度大约是2微米的层中的250微克的醋酸氯己定)。该长形构件具有在将其插入时使流体从导管内移位、由此将溶液转移到导管连接器的外部近端区域(端面和梯面)的额外的益处。抗微生物剂从帽溶解到移位的流体中,从而将连接器的近端消毒。此外,当流体干燥时,它将醋酸氯己定或其他适当的抗微生物剂涂层沉积在如上所述的连接器上。作为使用该长形构件的一个替代方案,醋酸氯己定或其他抗微生物剂可以通过涂覆在鲁尔尖端上来递送(例如在大约20微米厚的层中的250微克的醋酸氯己定)。在一些实现方式中,在长形构件上的至少10微克的醋酸氯己定对于许多生物是有效的。大于100微克的所希望的最小量对于大多数生物是有效的,250微克的另外的所希望的最小量针对所有的主要生物是高度有效的。
抗微生物剂的类型可以包括氯己定碱、醋酸氯己定、葡萄糖酸氯己定、EDTA、磺胺嘧啶银或牛磺罗定、或它们的组合。还可以使用其他抗微生物剂。醋酸氯己定是优选的,因为它具有长的人类使用历史,并且具有充分了解的安全性和有效性属性。
典型地,这些方法也与抗微生物剂在导管中的限制结合使用,例如通过依靠导管夹来将抗微生物剂限制在导管近端的一部分中(患者体外的导管部分,尤其是最接近导管上的连接器的部分,流体通过这个部分进入和离开导管)。延伸管夹是各血液透析导管的一部分,并且目前用于限制用来帮助确保导管通畅的锁定溶液。使用现有的夹紧方法,气栓与锁定溶液进入患者的风险是非常小的,并且与本领域的用于进行血液透析程序的当前状态是一致的。在其他医疗装置中,例如不具有导管夹的导管,可以使用可膨胀帽头或其他限制技术,如在美国专利申请公开号US 2010/0106103 Al中所述的那些。
还可以使用生物机械去除。在此方面,长形构件的一部分可以在去除时报废导管壁,例如通过将肋状物结合到该长形构件中。在一些实现方式中,在将长形构件放置在导管中之后,各向异性膨胀使肋状物(或其他突出物)抵靠壁移动,这样提供了一种在膨胀之后的抵靠壁的更紧密配合,并且进一步促进生物的机械去除。并且,长形构件的尖端有可能会膨胀(或例如肋状物的其他部分膨胀),或者沿着长形构件的长度方向膨胀。优选地,当长形构件被插入时,长形构件的未膨胀直径小于导管内腔,但是膨胀来适应导管内腔的内部形状(或更大),从而增强在去除过程中生物的机械去除。各种聚氨酯或其他材料可被用于产生适合的各向异性膨胀和机械稳定性,更具体地说,路博润(Lubrizol)1065D适合于非膨胀长形构件,TG-500适合于各向异性膨胀(或各向同性膨胀)尖端,可以使用热粘合或其他适合的方法来使其互相粘合。
本发明的一个实施例,在此被称为“帽”,包含一个可以被插入到一个医疗装置例如导管或引流管中的长形构件,用于通过提供一种抗微生物剂和/或物理屏障来防止和处理在医疗装置内以及在该长形构件附近的感染性生物并且进一步防止感染性生物迁移到身体中。为了简单起见,术语“导管”用于可将本发明插入并用于处理、防止和消除感染性生物的所有医疗装置。可将帽从导管上去除以允许导管在透析过程或其他过程中使用。在该过程完成之后,可以使用一个新的帽密封和保护该导管。去除一个帽并更换一个新的帽可以重复无限次。使用每一个新的帽,导管内及导管外的抗微生物剂被恢复。本发明的另一个方面在于随着每次使用将抗微生物剂从帽转移到导管。
一个示例实施例包括一个狭长杆,该狭长杆包含一种适合的材料,一种抗微生物剂已经结合到该材料中。如这里所用的术语“抗微生物剂”包括杀死或抑制生物(例如细菌、真菌、原生动物、病毒等等)的生长的任何物质或多种物质。还应当注意的是,可以使用一种或多种抗微生物剂。因此,在本文中,抗微生物剂是指一种或多种抗微生物剂。虽然本发明可以用在许多种医疗装置中,一种导管,更具体地说是长期血液透析导管,将被用来描述本发明的用途。使用这些实例并不意味着将本发明的用途局限于或限制在其他类型的导管或医疗装置中,例如腹膜透析导管、导尿管、PICC线、中心静脉导管、饲管以及引流管。
本发明的一个有用的应用是在带有血液透析导管的人们中防止感染。通过提供一种用于延长抗微生物剂的存在的手段和/或提供一种用于定时擦洗导管的内腔壁来去除生物膜(感染性生物在其中增殖)的手段,本发明防止或消除在导管的连接器和腔壁上的感染性生物。
用于防止、消除和处理在导管的内腔中的感染性生物的竞争方法的使用受到限制。一种方法在导管的内壁上或内壁中使用一种抗微生物涂层。排除广泛使用的问题包括该抗微生物涂层最后逐渐耗损,失去效力,或者变得被血液制品覆盖,使涂层无效。当将抗生素用作抗微生物剂时,存在着关于针对抗生素的耐药生物的出现以及对抗生素过敏的风险的另外的担心。用于处理在内腔中的感染性生物的另一种方法是使用一种抗生素或抗微生物液,称为锁定剂或锁定溶液。在这个方法中,将抗微生物流体注入导管,并且将一个帽附接到导管的接口部位(hub),用来防止流体漏出导管并用来防止感染性生物进入内腔。
排除这种方法的广泛使用的一个问题是担心如果使用抗生素会出现耐药菌。然而,这种担心实际上可以通过使用非抗生素抗微生物剂(例如牛磺罗定)来消除。当透析管充有锁定溶液时的另一个问题是,该锁定溶液会溢出到血流中。出现这种情况的原因有两个。首先,当导管的填充体积等于导管容量时,由于导管中的层流剖面的性质,一个重要部分的流体漏出。第二,经由尖端/远端的血流导致注入导管的锁定溶液由于文丘里效应而被拉出,并且锁定溶液之间的密度差导致该溶液溢出到血流中。已经报道60%或更多的锁定溶液在滴注之后最初几个小时内溢出到血流中。意外过量,无论是由于锁定溶液的注入体积太大还是浓度太高,可以引起另外溢出到血流中。溢出导致不良事件,包括死亡。例如,当使用柠檬酸溶液时,溢出导致了由一过性低血钙引起的死亡。另外,随着一些类型的锁定溶液在体内积累,可能出现其他不良事件。
在使用带有透析管的帽的情况下,本发明被设计为在每次透析之后定期更换,每周大约3次。这样随着每次更换而补充抗微生物剂,导致在正在进行的导致降低感染的风险的基础上存在于导管内和导管上的抗微生物剂的一致的高浓度。然而,这种限制方法,例如夹子,当与本发明结合使用时,防止显著量的抗微生物剂经常泄漏到血流中。
另外,在抗微生物剂与血液之间的分离可以导致感染率较低、副作用较少、以及由于使用非抗生素抗微生物剂而使产生耐药菌的风险更小。在某些实施例中,本发明在血液与抗微生物剂之间产生了一种物理屏障。该屏障大大降低了抗微生物剂与在体内循环的血液的交换,导致抗微生物剂的副作用较少。这可以导致沿着与帽相邻的导管的长度方向的抗微生物剂的更一致的水平。另外,该屏障降低了进入血流的抗微生物剂的量,从而减少抗微生物剂的不良反应或使生物产生抗该抗微生物剂的风险。相比较而言,众所周知,液体锁定剂可能并且的确常规地迁移到向血流中,然后血流可以迁移到导管中,从而降低了抗微生物剂的效力,增加了细菌进入血流的可能性,并增加了在导管中的血栓形成率。用进入内腔中的流体药剂冲洗导管内腔的行为将导致血液从该内腔中移除,并且由此降低血栓形成的风险。如果该液体试剂是一种抗血栓锁定剂,例如肝素化盐水或含有4%柠檬酸钠的盐水,则血栓形成的风险进一步降低。使用限制手段,如在本发明中描述的作为可膨胀长形构件尖端、可膨胀长形构件、或导管夹,防止血液重新进入内腔并导致较低的在内腔中的血栓形成风险。
本发明的另一个方面涉及在使用之前以及在处理期间保护帽免受污染,以便在将其插入到导管中之前保持长形构件和鲁尔接头无菌。可以使用长形构件和鲁尔接头上的护罩。保护一个鲁尔接头和长形构件的标准护罩适合于保持一个长形构件和鲁尔接头无菌。此后描述了一种新型护罩,在维持无菌保护的同时改进了处理,并且促进了低成本注塑成型。该新型护罩将两个帽保持在一个护罩体内,其中这两个帽以轴向偏移的方式反向180度保持,其中两个长形构件的至少一部分沿轴向彼此重叠,在两个帽之间具有一个物理屏障。该护罩可以具有螺纹,以便提供一种用于将帽可移除地附接到该护罩上的手段。这种新型配置允许用户握住一个部件,而不是两个部件,这样易于处理并降低帽落下的风险。当一个帽从护罩上移除时,在两个帽之间的屏障确保另一个帽保持无菌。固定在护罩内的帽还可以被包装在一个使用适合的包装材料(例如具有促进热密封的聚合物层压片的金属膜)制成的小袋内。该金属层对于将湿度的不利影响降到最低是有用的。可以使用γ辐射或其他适合的灭菌方法将在小袋内的装置灭菌。当产品被包含在防潮包装内时,γ辐射具有对产品有效灭菌的优点。
本概述是本申请的一些传授内容的综述,并且不是旨在是本主题的排他的或穷尽的处理。进一步的细节见于详细说明和所附的权利要求书中。在阅读并理解了以下详细说明并查看了形成其一部分的附图之后,其他方面对于本领域的技术人员将是清楚的,其中的每一者都不应当被理解为限制性意义。本发明的范围是由所附权利要求书及其法律等效物限定的。
在过去二十多年以来,防止导管相关血流感染(CRBSI)的研究和开发集中于用于杀死沿着导管的内部和外部长度的细菌的方法。本研究已经在降低一些导管类型中的CRBSI发生方面取得了成功。例如,商业上成功的抗微生物剂涂覆导管已经导致在使用短期(非隧道式)导管的应用中降低感染发生。然而,这些涂层随着使用被洗掉,并且因此对于长期应用无效。长期(通道式、带套囊的)血液透析导管的使用在每1000个导管日中引起大约2.3次血流感染。所述的另一种方式,用血液透析导管透析的患者可以预期在平均每14个月产生一次血流感染。为了解决这个保留的问题,许多当今的研究都集中于消除导管内的生物膜的方法并且集中于产生能够杀死导管内的生物的更持久的抗微生物涂层的方法。
感染性生物通常以三种截然不同的方式定植于导管。第一,感染性生物可以通过在血流中行进并最后附着在导管上而定植于导管。这种传播形式被认为是罕见的。第二,感染性生物可以通过在进入导管的身体出口部位之后沿着导管的外壁行进而定植于导管。已经通过使导管隧穿在皮肤下持续几厘米、并且通过在导管外壁上添加套囊大大降低了这种感染传播方法。身体组织生长到套囊中并且产生一种感染屏障。第三,感染性生物可能在导管内腔中定植,在导管连接器的接口部位和/或接头处进入,最终顺着导管内腔向下迁移到血流中。这种感染传播方法是在具有长期留置导管的患者中的血流感染的主要原因。因此,对于用于消除、处理和防止这种污染的改进的装置、系统、以及方法存在着需要。
通过提供一种用于延长抗微生物剂的存在的手段和/或提供一种用于定期擦洗导管的入口区域和/或内腔的手段或去除感染性生物以及感染性生物在其中增殖的生物膜的其他医疗装置,本发明可以防止、减少、甚至消除来自导管或管的进入区域以及来自导管或其他相似医疗装置的内腔表面内的感染性生物。
本发明包括用于杀死生物并且防止在导管中的生物增殖和生物膜形成的方法和装置,这样使得生物不能退出导管并进入患者的血流中。通过采用以下三种防止方法中的任何一种或全部,本发明的物品防止或减少了到达血流的生物的数量:1)物理阻断生物迁移到导管外,2)沿着螺纹、端面及鲁尔连接器(连接器的内部和外部)在导管的近端(身体的外部)使用一种抗微生物剂来杀死生物,和/或3)在导管的限制区域内使用一种抗微生物剂和/或在导管内腔中的一种物理屏障来杀死生物。第四种作用方式,擦洗导管壁(以便在将帽从导管中移除时将附着在内壁部分的生物物理去除)也可以与其他方法和装置结合使用。
正如上面所提到的,本发明部分地涉及一种在导管内的抗微生物剂。该抗微生物剂可以作为一种被涂覆在长形构件上(或浸透在其中)的从被涂覆的长形构件上洗脱出的涂料而被递送(例如沿着一个长17mm x直径1.9mm的长形构件/杆的一个厚度大约是2微米的层中的250微克的醋酸氯己定)。该长形构件具有在将其插入时使流体从导管内移位、将溶液转移到导管连接器的外部近端区域(端面和梯面)的额外的益处。抗微生物剂从帽溶解到移位的流体中,从而将连接器的近端消毒。此外,当流体干燥时,它将醋酸氯己定或其他适当的抗微生物剂涂层沉积在如上所述的连接器上。作为使用该长形构件的一个替代方案,醋酸氯己定或其他抗微生物剂可以通过涂覆在鲁尔尖端上来递送(例如在大约20微米厚的层中的250微克的醋酸氯己定)。鲁尔接头部分还涂有抗微生物剂(例如在大约0.4微米厚的层中的50微克醋酸氯己定)。还可能使用注射器将一种抗微生物剂注入导管,或通过连接器尖端腔递送抗微生物剂(干的可溶量,适用于柠檬酸盐或其他需要大量抗微生物剂的情况)。
现在参考附图,显示了本发明的实例实现方式。图1A显示了双罩系统10"的分解视图,双罩系统10"包括动脉帽20'、静脉帽20"和护罩50";颜色通常被选择为与在血液透析中使用的标准颜色匹配:红色用于动脉帽20',并且蓝色用于静脉帽20"。双罩系统10"在同一个护罩50"中包含两个帽。护罩50"为处理更容易做准备,因为有更少的部件要处理和保持。双罩系统10"被包装在热封的箔袋内(未显示)并经过伽马消毒。在诊所在使用帽之前即刻打开箔袋。帽螺纹41与双罩螺纹59可拆卸地接合以便允许帽20'和20"从护罩50"轻松移除。平坦侧面57产生一个用于在帽20'和20"被移除时握持护罩的便利手段。另外,平坦面侧57破坏了护罩50"的旋转对称,从而使护罩系统10"抵抗滚到地板上或掉落。
图1B显示了双罩系统10"的横截面,双罩系统10"具有被插入护罩50"中的动脉帽20'和静脉帽20"。护罩50"被设计为保持帽20'和20"轴向偏移,如由动脉帽轴54'和静脉帽轴54"所示。偏移轴优于同轴设计,因为它减少了系统10"的长度,允许它配合一个较短的小袋中,并使其更容易处理。另外,帽20'和20"以180度彼此相对,从而使得保持环第40'和40"彼此物理分离。这使得保持环40'和40"更容易握持,因为动脉保持环40'没有物理阻挡手指接近静脉保持环40",反之亦然。护罩50"为帽20'和20"提供保护,并且进一步有助于维持在使用之前无菌,因为帽20'和20"各自被壁56"分开。在一个示例实施例中,公鲁尔接头31的最近端部分31'与双罩50”的接收边缘58接触。公鲁尔接头31的其余部分不与壁56"接触,从而将公鲁尔接头31上的抗微生物涂层去除的风险降到最低。典型地,长形构件33也不与壁56"接触,以便将去除抗微生物涂层的风险降到最低。
图2A显示了具有帽20和护罩50'的单罩系统10'的透视图。护罩50'在壳体内包含一个帽。单罩系统10'被包装在热封的箔袋内(未显示)并经过伽马消毒。在诊所在使用帽之前即刻打开箔袋。帽螺纹41与单罩螺纹59可拆卸地接合以便允许帽20从单罩50'轻松移除。
图2B显示了具有被插入到单罩50'中的帽20的单罩系统10'的截面视图。单罩50'对帽20提供保护,并且进一步确保其在使用之前无菌。这是通过由壁56"围绕帽20来实现的。在一个示例实施例中,公鲁尔接头31的最近端部分31'与单罩50'的接收边缘58接触。公鲁尔接头31的其余部分不与壁56'接触,从而将去除公鲁尔接头31上的抗微生物涂层的风险降到最低。优选地,长形构件33也不与壁56'接触,以便将去除抗微生物涂层的风险降到最低。
图3A显示了根据本发明的一个示例性实现方式制造的帽20。帽20可以被注塑成型成为热塑性聚合物树脂外的单个单元,以允许以低制造成本进行大批量生产。适合的聚合物将产生一个耐久部分,这样使得长形构件33可以弯曲而不断裂。具有最低断裂伸长率100%的聚合物是优选的。另外,该聚合物将典型地允许溶剂(被用在抗微生物剂涂覆过程中)均匀地润湿表面直到溶剂蒸发为止,并且抗微生物剂应当很好地附着在表面上,这样使得涂层在处理过程中不会剥落或掉落。可以使用各种聚合物材料来满足这些要求,例如聚酯、尼龙、聚醚酰亚胺、聚丙烯、聚氯乙烯或其他相似材料。可替代地,长形构件33可以由用抗微生物剂浸渍的可溶解材料制造,由此当长形构件33溶解时该抗微生物剂被释放到溶液中。
帽20的多个部分典型地用抗微生物剂涂覆和/或浸渍。在一个实施例中,将抗微生物剂作为涂料施用,任选地以不同的量施用到长形构件33、公鲁尔接头31和帽螺纹41上。抗微生物剂还可以被结合在本体聚合物材料内,但涂覆在表面上是优选的,因为表面涂层一般比增量剂更迅速地释放到溶液中;另外,表面涂层倾向于比增量剂需要更少的总抗微生物剂,因为在表面上的抗微生物剂更容易溶解。在一些实现方式中,使用了表面涂层与结合到本体聚合物材料中的组合。
涂覆帽20的适合的方法是喷涂和浸渍,其中喷涂是所希望的,因为施用到每个区域(长形构件33、公鲁尔接头33、以及帽螺纹41)的抗微生物剂的量可以更容易地在不影响定位于其他区域上的量的情况下调节。
图3B显示了根据本发明的一个实施例制造的帽20的横截面。长形构件33的长度和直径被确定尺寸为与医疗装置配合。在此所述的实施例中,该导管是一种血液透析导管。公鲁尔接头31和帽螺纹41可以按照国际标准化组织标准ISO594-2:1998(E)来制造以便与所有按照该标准制造的血液透析导管相配。
图4A描述了血液透析导管70,用于与本发明的一个实施例结合使用,并且显示具有在动脉接口部位72'中的动脉帽20'以及在静脉接口部位72"中的静脉帽20"。当血液透析患者使用时,双腔管87部分地隧穿在从上胸部到颈静脉的患者皮肤下。双腔管72"进入颈静脉并继续,直到导管尖端89处于心脏的右心房区域中。动脉内腔88'从动脉接口部位72'在导管70内接口部位72运行直到在导管尖端89处退出。同样地,静脉内腔88"是在导管70内运行,直到它在靠近导管尖端89处退出。如果细菌或真菌在内腔第88'和88"中的任一者或两者中,这些导致感染的生物可以进入血流并导致全身血流感染,因此防止微生物进入导管70并生长是重要的。该导管包含一个接合点86,其中延伸管80从具有两个内腔的两个管过渡为具有两个内腔的一个管;这两个内腔第88'和88"从接口部位72'和72"到导管尖端89在导管70的整个长度上接口部位72运行而没有与其他内腔流体连接。动脉接口部位72'附接到一个延伸管80的近端,并且静脉接口部位72"附接到另一个延伸管80的近端。在所描述的实施例中,夹子84被定位在各个延伸管80上,从而允许内腔中的流动被阻断或打开。在实践中,除了在透析期间或其他转移在导管70内液体的期间之外,夹子84是闭合的。夹子84通常在每次打开夹子84时被重新定位,以便将由多次夹持在同一位置而引起的损坏延伸管80的风险降到最低。
参考图4B,显示夹子84定位在接口部位72附近。当闭合时,夹子84产生一个阻断在内腔中的流体流动的夹点85。优选地,长形构件33将足够短,以确保夹子84不会夹在长形构件上。另外,长形构件33必须具备一个足够小的直径,以确保它可以物理地配合在接口部位内腔79内。在长形构件33是长的足以进入延伸管80的实施例中,延伸管的直径也必须配合在延伸管内腔82内。优选地,长形构件33应当足够硬,以允许插入接口部位72中而不需要鞘、管或其它插入辅助件。
长形构件33的表面积应当足够大,以允许所希望量的抗微生物剂通过使用喷涂或浸渍操作而被涂覆在表面上(或其他施用方法,包括直接结合到长形构件中)。表面区域通常被确定大小为产生可接受的溶出速率,这样使得抗微生物剂以可接受的速率和剂量进入锁定溶液90。所希望的是,抗微生物剂在帽20被插入导管70的一个小时之内达到一个有效水平。
如果长形构件延伸到夹子84的夹点85中,它可能会引起锁定溶液90损坏或泄漏。因此,长形构件33的长度应足够短,以确保它不会到达夹具84的夹点85。对于长形构件33的适合直径包括1.0mm至2.0mm;以及1.7mm至1.9mm。适合的长度包括,对于长形构件33小于20mm,可替代地小于30mm、小于40mm或小于10mm。特别希望的长度是17mm至19mm,但在用不同导管时可以变化。
参考图4C,描述了一个实施例,显示了如在图4B中指示的端部截面视图A-A,显示帽20被完全插入到导管接口部位72中。当完全插入时,公鲁尔接头31与母鲁尔接头75接触而产生一种流体紧密密封。帽螺纹41与导管螺纹78接合而将帽20保持在接口部位72上。然而,在帽20被完全插入接口部位72中之后,在保持环40与接口部位72之间存在空隙94。这个空隙94可以是致病生物沿着其行进的一个途径,从而使得接口部位表面被在保持环40与接口部位72之间的区域中的致病生物污染。为了降低导管相关血流感染的发生,所希望的是减少或消除在这个区域中的致病生物的数量。
现在参考图5A至5C,显示了帽20的安装的不同阶段,其中帽(带有长形构件)的插入导致了含有抗微生物剂的液体流出导管接口部位的端部,将微生物杀死,否则微生物可能会侵入接口部位并且然后进入导管内腔中。在图5A中,帽20是在其被插入到导管70的接口部位72之前即刻显示的。在接口部位内腔79内是一种液体锁定溶液90,其最近端部形成一个弯液面92。血液透析导管的锁定溶液最常用的是肝素化盐水(100IU/ml至5000IU/ml肝素)、柠檬酸钠溶液(通常是4%柠檬酸钠)、或盐水。培训患者护理技师和护士来保持接口部位72的近端74的弯液面92。然而,弯液面在接口部位内腔79内下降几毫米很平常的。抗微生物剂必须在任何标准锁定溶液中产生所希望的效果。在实践中,除非流体通过导管70转移,夹子84保持闭合(产生夹点85);这是标准的实践,因为它降低了通过导管70将气栓引入患者血流中的风险。
参考图5B,显示了长形构件33部分地插入到接口部位内腔79中。长形构件33使锁定溶液90移位,导致弯液面92被推出内腔90并被推到接口部位70的端面76上。最后,当帽20继续被插入时,弯液面92(以及锁定溶液79)将在导管螺纹78上行进。
接着,参考图5C所示,显示帽20被完全插入到导管70中。在这个实施例中,弯液面92行进超过空隙94,从而用锁定溶液完全填充空隙94。该锁定溶液引起抗微生物剂溶解,导致抗微生物剂从一个或多个涂覆的部分(长形构件33、公鲁尔接头31、以及帽螺纹41)转移到溶液中。另外,将长形构件插入到锁定溶液中进一步引起抗微生物剂转移到先前未被涂覆的部分,例如限定内接口部位内腔79以及延伸内腔82的壁、母鲁尔接头75、端面76以及导管螺纹78。在几个小时之内,在空隙94内的溶液可以干掉。以这种方式,抗微生物涂层被转移到导管螺纹78和端面76,导致杀死在导管螺纹78和端面76上的任何生物的能力增强,即使在溶液干燥之后生物污染表面的情况下。在实践中,该空隙往往渗入了包含生物的汗液。在这种情景下汗液将干燥的抗微生物剂水化,从而杀死可能存在于汗液中的生物。此外,在每次插入新的帽20时,导管螺纹78和端面76被补充有抗微生物剂。在当前实践中,在每次透析之后使用一个新的帽。帽20的将导管70上的抗微生物剂补充到一个具有作为微生物源的高度风险的目标位置中的能力克服了抗微生物剂涂覆的导管的显著缺点(其中抗微生物剂随着使用渐渐减少或仅仅被施用到导管的内部)。在导管螺纹78上的抗微生物剂的所希望的量是20微克至2毫克、可替代地200微克至1.5毫克、以及令人希望地500微克至1.2毫克的醋酸氯己定。然而,应当理解的是,不同的水平也可成功实现。
使公鲁尔接头31与母鲁尔接头75接触以产生一种流体精密密封。这些部分通常是按照国际标准化组织标准ISO 594-2:1998(E)制造的,以确保正确的密封和互配性。然而,在公鲁尔接头31与母鲁尔接头75之间的接合点在沿着接口的整个长度上不是流体密封的。一些医疗装置接口部位的制造商有意制造了其母鲁尔接头,使得公鲁尔接头与邻近该公鲁尔接头的端面的母鲁尔接头接触。这样做是为了降低接口部位裂开的风险。然而,意想不到的结果是,鲁尔接头界面的近端允许潜在的生物渗入。一旦生物存在,当下次插入一个帽(或其它装置)时,它们可被进一步经由当前的帽(或其他装置)推入接口部位内腔79中。一旦生物在接口部位内腔中(公鲁尔接头的远端),它们可以繁殖,导致浮游生物和固着生物,并且最后形成生物膜。这个问题可以通过沿着公鲁尔接头31放置一种抗微生物剂来解决。在生物有机会被推入接口部位内腔79或进一步繁殖之前,该抗微生物剂将沿着母鲁尔接头75可能存在或已经存在的生物杀死。即使有这些保护措施,仍然存在着一些生物可使其超过母鲁尔接头75的可能性。为了克服那种潜在的缺点,优选的实施例还含有在长形构件33上的抗微生物剂,该抗微生物剂可溶解或洗脱到锁定溶液90中来杀死在接口部位内腔中的生物。
在长形构件33上的抗微生物剂的最小量是通过实验室测试来确定的,在测试中,将长形构件在多种锁定溶液和激发生物存在下放置在导管中。锁定溶液的类型在盐水、肝素化盐水、4%柠檬酸钠溶液、以及人血清之中变化。使用了许多种激发生物,例如白色念珠菌、铜绿假单胞菌、金黄色葡萄球菌、以及大肠杆菌。由本发明人进行的测试显示了剂量响应;包含在长形构件33上的醋酸氯己定越多,在导管70中杀死的生物越多。
通过首先评审对于患者是安全的抗微生物剂的量是多少,然后将其与患者可能通过每个含有抗微生物剂的帽20的表面(长形构件33、公鲁尔接头31以及帽螺纹41)暴露的抗微生物剂的量是多少进行比较,研发了被放置在每个帽的表面上的抗微生物剂的最大量。通过评审通常被认为对于患者是安全的水平(尤其是血流水平)的公开信息,确定了对于患者是安全的抗微生物剂的量。
进行测试是为了获得患者可以潜在地暴露于来自帽20的抗微生物剂是多少。该测试被设计为确定从各个适用组件(长形构件33,公鲁尔接头31、以及帽螺纹41)到血流的抗微生物剂的转移效率。为了确定可能的血流水平,考虑了在各种条件下可能发生的潜在的患者暴露,包括不寻常的使用或误用(例如将锁定溶液注入患者的血流中,而不是抽出该溶液)。针对各组件以及针对整个帽20,逐一确定了潜在的患者暴露。
在长形构件33上的抗微生物剂的最小量是获得引起感染的生物的可接受的减少(也称为杀死)所需要的量。对于理解抗微生物剂溶解进入其中的溶液的体积是重要的,因为存在的溶液越多,抗微生物剂可能被稀释越多。在内腔内的锁定溶液90的限制体积是由弯液面92的位置、接口部位内腔79的几何形状、延伸内腔82的几何形状、以及夹点85的位置定义的。由于每一个这些项目可以变化,存在一个相当大范围的可能的限制流体体积。在考虑现有的血液透析导管的设计变化之后,很显然优选的实施例需要在0.7ml的体积内产生抗微生物剂的治疗浓度。在一个实施例中,在长形构件33上的醋酸氯己定的量较大,是10微克至5mg。在一个替代实施例中,醋酸氯己定的量是100微克至2mg。在又另一个实施例中,长形构件含有250微克至550微克。
这些实施例可以产生对目标生物的广谱杀死,还导致足够低的剂量的醋酸氯己定,即使将含有醋酸氯己定的所有锁定溶液直接注射到血流中,也将导致保持在安全水平的血流水平。
参考图6,显示帽20被完全插入到导管70中。这个实施例包含端部密封件47。通过防止微生物进入远端开口44,从而防止微生物随后通过空隙94(在空隙94中它们然后可以污染端面76和母鲁尔接头75)前进,端部密封件47提供了另外的益处。减少可以进入远端开口44的生物的数量可以进一步降低CRBSI的发生。端部密封件47可以由弹性材料制成,因此它能够在插入帽20时伸展跨越导管螺纹78,并且它也应当符合接口部位72的形状,这样它产生有效的生物阻断密封。端部密封件47优选地由耐久材料制成,因此它不会裂开或撕裂。它应当足够薄和柔韧,因此容易插入。在将帽20插入到导管70中时,端部密封件44允许流体逸出,还充当基本上保留在插入过程中被推入空隙94中的锁定溶液的屏障。在优选实施例中,这是通过保持壁足够薄和柔韧以允许增加的压力从端部密封件47与接口部位72接触的位置释出来实现的。在一个示例实施例中,端部密封件47是被成型在保持环40上。可以使用一种热塑性弹性体,例如埃克森美孚公司(Exxon Mobile)的山都平(Santoprene)。然而,其它材料,例如硅酮,可以是适合的。在一个实施例中,端部密封件47的厚度范围是0.005英寸到0.100英寸。在另一个实施例中,端部密封件47的厚度范围是0.010英寸到0.040英寸。
在空隙94中的锁定溶液也可作为生物渗入的屏障。它包含已经从帽20的表面(长形构件33、公鲁尔接头31以及导管螺纹78)溶解的抗微生物剂。在一个所希望的实施例中,该抗微生物水平导致高度有效地杀死广谱微生物的抗微生物剂浓度。
参考图7,显示了帽20在横截面上完全插入到导管70中。这个实施例可以包含浸渍有抗微生物剂的螺纹密封件48,抗微生物剂的量与图5C的帽螺纹41上的量相同(并代替之)。通过防止微生物进入远端开口44并且,因为空隙94现在被螺纹密封件48占据,它防止微生物通过被占据的空隙94(否则在空隙94它们会污染端面76和母鲁尔接头75)前进,端部密封件48提供了另外的益处。减少可能进入远端开口44的生物的数量可以进一步降低CRBSI的发生。端部密封件47'优选地由一种弹性泡沫材料制成,这种材料能够在插入帽20时适应在导管螺纹78周围,并且它还应当符合接口部位72的形状,这样它产生有效的生物阻断密封。螺纹密封件47'的最远端往往具有一薄层闭合聚氨酯来帮助减少溶液的蒸发。螺纹密封件耐久48优选地由耐久材料制成,因此不会裂开或撕裂。端部密封件48的一个方面在于,在将帽20插入到导管70中时它允许流体释出,还充当基本上保留在插入过程中被推入被充盈的空隙94中的锁定溶液的屏障。在该优选实施例中,这是通过从开孔的亲水性医用聚氨酯泡沫制造螺纹密封件48并且在螺纹密封件47'的最远端具有一薄层固体聚氨酯来实现的。螺纹密封件47'的远端令人希望地是薄的,例如0.001至0.020英寸,并足够柔韧,以允许增加的压力从与其接触的接口部位72处释出。螺纹密封件48以及结合在其中的抗微生物剂还充当防止生物渗入的屏障。它包含已经从帽20的表面(如长形构件33、公鲁尔接头31以及螺纹罩48中的一个或多个)溶解的抗微生物剂。
图8A指的是帽20的一个替代实施例,帽20具有新型尖端34',当将尖端34'插入到导管70中时,尖端34'的直径小于接口部位内腔79的直径,但是随后尺寸扩大。当帽20被用在不具有用于限制溶液的夹子的导管70中时,或在需要进一步限制所需的抗微生物剂的量(因为限制的溶液的体积较低而需要较小的量)的情况下,这个实施例是特别有益的。在图8A中显示了尖端34',尖端34'在插入过程中处于其未膨胀状态以便允许长形构件轻松插入并将它的通过犁地(plowing)动作将生物向远离尖端34'的方向推动的可能降到最低。在优选实施例中的长形构件在当它被插入到导管70中时保持足够硬,并且它不需要任何额外的零件或辅助件。
图8B是指如参考图8A描述的帽20的替代实施例,除了尖端34"是以其膨胀状态显示之外。在描绘的实施例中,处于其膨胀状态的尖端34"的直径等于接口部位内腔79的直径;尖端34"优选地在其膨胀时符合接口部位内腔79的表面。当被用于限制该溶液,或希望进一步限制所需的抗微生物剂的量(因为限制溶液的体积较低而需要较小的量)的情况下,膨胀的尖端34"是有益的。当向帽20施用合理的移除力时,尖端34"可从接口部位内腔79去除。这是通过选择尖端34"的材料和尺寸来实现的,这样当它处于其膨胀状态时,尖端34"向接口部位内腔79的壁施加的法向力是足够低的以允许可接受的去除力。在一个示例实施例中,未膨胀尖端34'(参考图8A)的直径是0.060英寸,被限制的膨胀尖端34"的直径是0.098英寸(与接口部位内腔79的直径相同),并且当被放在生理盐水中时,未限制的膨胀尖端的直径是0.110英寸。然而,这些直径将会变化以便与帽一起使用的装置的直径相匹配。优选的未限制的膨胀直径(如果尖端不被内腔壁限制,由尖端将扩大到的直径定义)略大于接口部位内腔79的直径。膨胀尖端的另外的有益效果是,它在导管壁上产生擦洗效应,这个效应将在从导管移除帽时物理除去附着在内壁部分上的生物。
在一个实施例中,该尖端被制造为产生各向异性膨胀,这样使得直径增加,但是长度基本上不增加。在另一个实施例中,整个长形构件是由各向异性膨胀材料制造的,这样使得直径增加,但是长度基本上不增加。
在一个实现方式中,尖端34"的材料包括可膨胀聚氨酯,例如已被热融合到长形构件33上的路博润TG-500,长形构件33是一种非膨胀聚氨酯,例如路博润1065D。这些材料提供可接受的膨胀、耐久性、强度和柔性。该长形构件涂覆有抗微生物剂,其用量足以获得足够的抗微生物作用,同时又足够低以保持对患者的安全性。
参考图9,本发明的这个替代实施例在因为导管的内径太小长形构件将不能配合到导管中(例如经外周静脉置入中心静脉导管(PICC))的应用中是有用的。在这个实施例中,帽20不包含如在前述的实施例中的长形构件。相反,该帽具有一个鲁尔接头端面38,端面38是平坦或轻微凹陷的,并且端面38涂覆有一个抗微生物层39。在抗微生物层39中的抗微生物剂的优选类型和量与长形构件相同(参考图5C的说明)。类似地,公鲁尔接头31和导管螺纹78优选地含有与其他实施例相同类型和量的抗微生物剂。优选地使用精密计量泵,用甲醇溶液中的15%的醋酸氯己定,将抗微生物剂施用到端面上。可以使用其他溶剂、百分比以及涂覆方法。
参考图10A,显示了本发明的替代实施例,其中,帽20”'是由两个部件(保持环40”'和插入件30)制造的。令人希望的是将具有高度控制且可重复的量的抗微生物剂放置在帽20”'的所希望的区域上。还优选在不同区域上具有不同量的抗微生物剂。如果保持环40”'未阻断进入公鲁尔接头31的通路,涂覆帽20”'的各个区域变得更容易(反之亦然)。这是通过将帽20”'制造为两个分开的零件(保持环40”'和插入件30)来实现的。在每个区域内的抗微生物剂的优选量保持与如上面呈现的量相同(是指参考5C)。
参考图10B,沿着长形构件33和公鲁尔接头31用醋酸氯己定涂覆插入件30。板32、帽肩台36以及保持凸缘37不需要涂层。两个被涂覆的部件是公鲁尔接头31和长形构件33;含有如以上所指的量相同的量的抗微生物剂。
参考图10C,板32在插入件30的近端处具有孔35。孔35的目的是为了改进制造。例如,孔35产生一个方便的特性,可以用于保持和旋转插入件30,以便允许该部件在其被涂覆时旋转。孔35还通过产生更均匀的壁厚来降低注塑成型插入件30中的收缩率。
参考图10D,保持环40”'是一种来自威璐塑件有限公司(Value Plastics,Inc.)的可商购的产品,不同之处在于该帽螺纹41被一种抗微生物剂涂覆。在该优选实施例中的抗微生物剂是如在上文披露的相同的优选量的醋酸氯己定。使用喷涂技术容易地涂覆保持环40”',其中保持环40”'沿着其轴线旋转,并且抗微生物剂被直接喷到帽螺纹上。作为一种替代涂覆方法,通过用7%氯己定甲醇溶液填充环40”'的内部,随后排出溶液并允许部件干燥来涂覆帽螺纹41。这导致在帽螺纹41上的大约1.2mg的醋酸氯己定。抗微生物剂的剂量可以通过调节溶液的浓度来调整。
参考图10E,当插入件插入保持环40”'内时,保持肩台46与插入件(未显示)接触。近端开口43用于在组装过程中最初接收插入件30(参考图10F)。保持指45被设计成将保持环40”'保持在插入件上,如将参考下文所述的。环肩台46有助于固定该插入件。
参考图10F,显示了两件式帽20”'的优选实施例。显示插入件30被完全插入到保持环40”'中。将尖端34通过近端开口推动,直到保持环40”'在板32上降至最低点。保持指45与保持凸缘37接合以将保持环40”'固定在插入件30上。
令人希望的是使保持环40”'在插入件30上不能自由旋转。相反,优选的是使扭矩大于0磅-英寸(lb-in),但小于2.0lb-in。在一个更优选的实施例中,扭矩是在0.1lb-in与1.25lb-in之间。在最优选的实施例中,扭矩是在0.2lb-in与0.5lb-in之间。通过控制插入肩台36的直径,使得它干扰环肩46,可以控制扭矩,如在图11中所描述的图中所示的。
优选的是将环肩台46与插入肩台36之间的过盈保持在0.002英寸与0.009英寸的范围之内,以便将旋转扭矩保持在可接受的范围之内。
抗微生物剂
可以使一种抗微生物剂结合到长形构件材料中和/或在本发明的长形构件的表面。在一个优选实施例中,该抗微生物剂是醋酸氯己定;将大约250微克醋酸氯己定涂覆到一个长17mm x直径1.9mm的杆状长形构件上,导致大约2微米厚的醋酸氯己定层。鲁尔接头部分被涂覆有50微克醋酸氯己定,导致一个大约0.4微米厚的层。还有可能使用注射器将一种抗微生物剂注入导管中,或通过连接器尖端腔(干燥可溶量,适用于柠檬酸盐或其他需要大量的抗微生物剂的情况)递送抗微生物剂。
该长形构件具有在将其插入时使流体从导管内移位、将溶液转移到导管连接器的外部近端区域(端面和梯面)的额外的益处。抗微生物剂从帽溶解到移位的流体中,从而将连接器的近端消毒。此外,当流体干燥时,它将醋酸氯己定或其他适当的抗微生物剂涂层沉积在如上所述的连接器上。作为使用该长形构件的一个替代方案,醋酸氯己定或其他抗微生物剂可以通过涂覆在鲁尔尖端上来递送(例如在大约20微米厚的层中的250微克的醋酸氯己定)。
一种抗微生物组合物被定位于长形构件、公鲁尔接头连接器以及保持环的外表面。在将长形构件/杆插入到导管中之后,该抗微生物组合物从长形构件上洗脱。当该系统被插入到导管中时,抗微生物剂溶解到包含在导管内的液体中,这样使得其与可能沿着连接器表面和导管的内腔壁或在溶液中存在的感染性生物接触。另外,该抗微生物剂和任何感染性生物一起被限制在导管内的小空间中。另一个益处是,夹子的限制行为可捕获导管内的任何传染性微生物,并且防止它们向导管的其他区域或向身体传播,从而防止全身性感染。
该抗微生物剂应当杀死革兰氏阳性和革兰氏阴性细菌和真菌和/或使其停滞。这些药剂可以具有杀死建立的生物膜内的生物和/或降解该膜的细胞外基质的效力。然而,这对于本发明的益处不是必需的,因为本发明被设计为在生物有机会形成生物膜之前将它们杀死。优选的抗微生物剂是醋酸氯己定,也称为氯己定二乙酸酯。还可以使用含有氯己定的其他化合物(例如氯己定游离碱、葡萄糖酸氯己定以及带有染料的氯己定)。醋酸氯己定优于葡萄糖酸氯己定,因为它可将与对氯苯胺相关的风险降到最低。还可以使用其他适合的抗微生物剂。通常地,优选的抗微生物剂是溶于水的,它们拥有具有证明的安全性的临床使用历史,它们不含抗生素,它们可以被施用到医疗装置中,并且它们可以随后溶解到具有有效浓度的组合物中来抑制细菌和真菌生物的生长。适合的材料包括依地酸四钠(EDTA四钠)、柠檬酸钠(产生30%或更高的浓度)、碘、牛磺罗定、EDTA二钠、银化合物(包括银纳米颗粒和离子)、磺胺嘧啶银、和三氯生。
虽然一种特定的药物或抗微生物剂可以缓解许多各种不同的可能潜在地引起导管相关血流感染的激发生物,也可以使用两种或更多种药剂来提高针对广泛的感染性生物(细菌和真菌)的效力。
具体地说,导管相关感染起因于三大类生物:真菌、革兰阴性细菌、以及革兰氏阳性细菌。如果一种抗微生物剂可以被鉴定将会消减这些类型的生物中的一种或两种,虽然这一定是有益的,但是它使患者对其余类型的生物是易感的。通过具有不同作用方式的配对剂,可以防止由增加的生物谱引起的感染。这种协同作用将很可能进一步降低与导管相关的发病率和死亡率,减少植入导管对患者生活质量的影响。抗微生物剂的优选组合是醋酸氯己定和EDTA、磺胺嘧啶银和十二烷基硫酸钠、以及磺胺嘧啶银和亚甲蓝。
尽管处理、防止以及消除感染性生物来防止感染是帽的主要用途,还可设想涉及与结合另外的药剂的附属益处。从长形构件上洗脱的抗血栓形成剂可以被用来改进当前用于锁定溶液中的肝素的作用。促进生物膜的细胞外基质(通常是由多糖组成)的降解的酶或药剂使得该帽能够被用于治疗以及预防。
原则上,抗生素(利福平、米诺环素等)可被结合到帽或相似装置中,并与非抗生素抗微生物剂一样有效。然而,连续暴露于一种抗生素可导致抗生素耐药性细菌菌株,例如耐甲氧西林金黄色葡萄球菌(MRSA)。因此,该优选实施例使用了一种从不是抗生素的子集中选择的抗微生物剂。如果,由于某种原因使用了抗生素,可以通过制备含有一种不同的抗生素的第二补充帽来降低产生抗生素耐药菌株的风险。通过使用两个帽以交替的方式进行连续透析治疗,对一种抗生素具有抗性的感染性生物能够被另外一种抗生素杀死。
已经进行了实验来检查本发明的优选实施例(被称为“Pursuit Vascular的ClearGuard HD”或“ClearGuardHD”)的性能。这些实验证明,ClearGuard HD如预期对于大幅度减少导管内的生物是有效的。以下重点说明这些实验中的两个。
在一项在Pursuit Vascular进行的实验中,涂覆的帽可采用单连接有效地将50微克以上的醋酸氯己定(也称为氯己定二乙酸盐)转移导管的螺纹上。这样的转移为导管提供了一种进一步减少随着本发明的每次使用补充的引起感染的生物的手段。10微克或以上的氯己定有效减少螺纹上的细菌及其他引起感染的生物,并进一步防止生物渗入导管的连接器端面、鲁尔接头和内腔。当醋酸氯己定在具有很低的它进入血流的风险的导管外使用时,具有广泛的安全性。在帽螺纹上的氯己定的优选范围是100微克至2500微克。500微克至1200微克是更优选的。
例如,如果使用基于氯己定的抗微生物剂,大约50微克的醋酸氯己定在一些实施例中是有效的。在Pursuit Vascular进行的实验中已经证明了这一点,其中在帽的鲁尔接头上涂覆50微克氯己定。含有被涂覆的鲁尔接头的帽杀死了接种在导管的鲁尔接头区域内的所有白色念珠菌。在相同的实验中,当使用未涂覆的帽时,白色念珠菌仍有活力。在鲁尔接头区域上的醋酸氯己定大于5微克是有效的;10微克至300微克是优选的,30微克至80微克是最优选的。
在Pursuit Vascular公司进行的实验室测试证明,当在含有盐水、肝素-盐水或含4%的柠檬酸钠的盐水的标准血液透析导管中使用帽时,在长形构件上的250微克醋酸氯己定产生了大于10,000倍的引起感染的生物的数量减少。通过限制进入血流的可用的醋酸氯己定的量,可以增强本发明的安全性,在长形构件上的醋酸氯己定的优选最大量是2000微克,更优选的是1000微克,并且最优选的是350微克。
实验1:这个实验的目的评估Pursuit Vascular的ClearGuard HD装置在最难的临床相关模型中的抗微生物有效性。由于ClearGuard HD预期被放置在导管接口部位处,但是未延伸到延伸管中,将该导管模型选择为母鲁尔连接器、延伸管和夹子。母鲁尔连接器和延伸管的总长度被制造为将预期会在临床上遇到的长度和容量最大化。白色念珠菌(真菌)被选择为激发微生物,因为在以前的试验中显示白色念珠菌是对ClearGuard HD根除的最具挑战性的微生物。将白色念珠菌加入到三种不同的锁定溶液中:肝素-血清、盐水-血清、以及SDB肉汤。这些溶液代表将会在临床上预期的最相关的(和最具挑战性的)溶液。用锁定溶液和白色念珠菌充入导管,下一步将帽(ClearGuard HD或标准帽)固定,并且然后将导管孵育大约46小时来模拟在透析阶段之间的时间。在孵育后,将帽移除,并且对锁定溶液针对生物的存在进行测试。
实验1的结果:在图11中显示了针对ClearGuard HD帽和标准帽的生物计数(分别显示为“有CGHD”和“没有CGHD”)。
*生物计数的实际减少很可能高于在这项测试中的计算值,因为在该研究的CGHD组中没有生物存活。
ClearGuard HD的抗微生物有效性是针对白色念珠菌的有效性来评估的,当在包含有最具挑战性的临床相关流体的临床相关导管模型中进行测试时,这种微生物是最难根除的。
使用ClearGuard HD的所有的试验样品都完全杀死了白色念珠菌。相比较而言,所有的对照样品表现出了CA的生长。由于在试验的ClearGuard HD部分过程中没有白色念珠菌存活,实际的白色念珠菌减少可能会显著高于(优于)这项试验的灵敏度。当使用ClearGuardHD来代替标准帽时,白色念珠菌的最小减少显示如下:a.对于含有25%的血清的肝素,是3.6x106CFU/ml,b.对于含有25%的血清的盐水,是3.8x103CFU/ml,c.对于SDB肉汤,是7.7x108CFU/ml。
这项试验表明,ClearGuard HD可在具有临床溶液的临床相关的导管内产生了白色念珠菌的显著减少。先前证明相对于测试的其他临床相关微生物,白色念珠菌是最难减少的生物,因此得出结论,ClearGuard HD产生了临床相关的微生物的广谱减少。
实验2
本实验的目的是当在一个模拟的临床环境中使用ClearGuard HD相对于使用标准帽时评估在血液透析导管内腔中的微生物污染的相对速率。这个实验旨在检验ClearGuardHD在防止血液透析导管内腔(延伸管夹的近端和远端)的微生物污染与在模拟临床环境中的标准帽相比的有效性。在导管内部使用生长培养基,而不是标准锁定溶液,以便提供一种极其灵敏的检测是否有任何微生物进入了导管内的手段。
引起感染的微生物进入血液透析(HD)导管并在其中定植的主要途径通常被公认是通过导管的接口部位。在临床使用过程中,血液透析导管接口部位经常暴露于微生物,因为导管和接口部位位于患者的皮肤上。所有可商购的导管帽主要被设计为将流体保持在导管内腔内部,但是它们没有被很好地设计用于防止微生物到达并定植在导管内腔中。
为了比较微生物定植率是否受到帽类型(ClearGuard HD对标准帽)的影响,将二十个相同的导管以保持这些导管与人皮肤保持接触的方式固定在衣服上,这是在临床使用过程中发生的方式。这些导管与皮肤保持接触持续最多26天。一旦确定导管的内腔被污染,允许将该导管从研究中移除。该试验包括两个组:1)ClearGuard HD组,以及2)标准帽组。除了所使用的帽类型之外,这两个组的所有其他方式是相同的(即,相同的导管、溶液、处理等等)。
该研究被设计为模拟尽实际可能接近的血液透析临床实践。锁定溶液的总体积,包括夹子远端的溶液,被包括在微生物测试中,以便以高概率确保如果在导管内的任何地方存在任何微生物,它们将会被检测到。使用标准微生物学技术来测试生物的存在。
随着时间的进展,没有微生物污染的导管的数目展示在下面的图13中。在十四天之内,所有使用标准帽的导管都已经被污染,而使用ClearGuard HD的导管在完整的26天的实验中没有一个被污染。
这个实验显示,当导管填充有生长培养基时,其被佩戴以模拟实际患者的最终使用并且经受标准透析液交换计划,使用标准帽的导管以8.9天的平均失效时间被微生物污染,并且所有这些导管(10个中的10个)到14天时均被污染。相比之下,在整个26天的试验中,使用ClearGuard HD的导管没有一个(10个中的0个)被污染。在模拟临床环境中,在减少导管内部的微生物污染方面,ClearGuard HD显著优于标准帽(当前护理标准)。虽然已经参考其实施例具体地显示并描述了本发明,本领域的技术人员将会理解的是,可以在其中在形式和细节上做出前述的以及其他的变化而不脱离本发明的精神和范围。
Claims (10)
1.一种用于将抗微生物剂递送到经皮导管的内腔中的装置,该装置包括:
被配置成放置在导管的近端的加帽构件;以及
被定位在该加帽构件的内部的抗微生物组合物。
2.根据权利要求1所述的用于将抗微生物剂递送到经皮导管的内腔中的装置,其中将该加帽构件放置在该导管中导致导管之内的流体的位移,该位移足以将流体导向该导管的近端的外部。
3.根据权利要求1-2中任一权利要求所述的用于将抗微生物剂递送到经皮导管的内腔中的装置,其中该加帽构件包括长形构件,该长形构件被配置成插入到该导管的近端中。
4.根据权利要求3所述的用于将抗微生物剂递送到经皮导管的内腔中的装置,其中该抗微生物剂被涂覆在该长形构件上。
5.根据权利要求1-2、4中任一权利要求所述的用于将抗微生物剂递送到经皮导管的内腔中的装置,该装置进一步包括一种在该加帽构件的螺纹上的密封件,该密封件被配置成限制微生物的行进。
6.一种用于将抗微生物剂递送到经皮导管的内腔中的装置,该装置包括:
长形构件,该长形构件被配置成被插入到导管的近端;以及
一种抗微生物组合物,该抗微生物组合物被定位成有待递送到该导管中;
其中在将该长形构件插入到该导管的近端时,该抗微生物组合物的一部分被递送到该导管的近端的外部。
7.根据权利要求6所述的用于将抗微生物剂递送到经皮导管的内腔中的装置,其中该微生物组合物被递送至该导管的近端的外螺纹上。
8.根据权利要求6-7中任一权利要求所述的用于将抗微生物剂递送到经皮导管的内腔中的装置,其中该微生物组合物被递送至该导管的近端的鲁尔连接上。
9.根据权利要求6-7中任一权利要求所述的用于将抗微生物剂递送到经皮导管的内腔中的装置,其中该长形构件包括可膨胀尖端部分。
10.一种将抗微生物剂施用到经皮导管的近端的方法,该方法包括:
提供经皮导管;
用锁定溶液填充该经皮导管的近端的至少一部分;
将经皮导管在靠近其近端处加紧以限制锁定溶液流动进入该经皮导管的远端;
将长形构件插入该经皮导管的近端,这样使得该长形构件使锁定溶液充分位移,以便使锁定溶液从导管的近端流动;
其中该长形构件包含一种抗微生物材料。
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Also Published As
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EP2731658A4 (en) | 2016-01-06 |
CA2841832A1 (en) | 2013-01-17 |
EP2731658B1 (en) | 2020-04-01 |
US20130184679A1 (en) | 2013-07-18 |
US20220226629A1 (en) | 2022-07-21 |
WO2013009998A2 (en) | 2013-01-17 |
CN103796704A (zh) | 2014-05-14 |
US9849276B2 (en) | 2017-12-26 |
WO2013009998A3 (en) | 2013-04-04 |
CA2841832C (en) | 2019-06-04 |
US20240050729A1 (en) | 2024-02-15 |
US11826539B2 (en) | 2023-11-28 |
EP2731658A2 (en) | 2014-05-21 |
CN106902405B (zh) | 2020-12-11 |
CN103796704B (zh) | 2016-12-07 |
US20180200500A1 (en) | 2018-07-19 |
ES2797649T3 (es) | 2020-12-03 |
EP3714932A1 (en) | 2020-09-30 |
US11389634B2 (en) | 2022-07-19 |
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