CN108578877B - 具有抗微生物针润滑油的血液控制导管 - Google Patents

具有抗微生物针润滑油的血液控制导管 Download PDF

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CN108578877B
CN108578877B CN201810233055.5A CN201810233055A CN108578877B CN 108578877 B CN108578877 B CN 108578877B CN 201810233055 A CN201810233055 A CN 201810233055A CN 108578877 B CN108578877 B CN 108578877B
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antimicrobial
catheter
septum
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马亦平
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Becton Dickinson and Co
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Abstract

涂布于导引针(50)外表面上的作为导管组件装置(10)的组成部分的抗微生物润滑剂(60)。该导管组件装置还包括具有缝隙血液控制隔膜(20)，通过该缝隙(26)穿过导引针。在插入导管后，当从缝隙中取出针时，抗微生物润滑剂被涂刷或从导引针的外表面上被除去。除去的抗微生物润滑剂沉积在隔膜上邻近缝隙的位置上，由此防止病原体在隔膜和导管组件装置的其它相邻组件和表面上定殖和生长。

Description

具有抗微生物针润滑油的血液控制导管
本分案申请是基于申请号为201480023495.8、申请日为2014年3月6日、申请人为“贝克顿·迪金森公司”、发明名称为“具有抗微生物针润滑油的血液控制导管”的原始中国专利申请(原国际申请号为PCT/US2014/021378)的分案申请。
发明背景
本发明涉及用于皮肤侵入性装置的润滑剂。特别地，本发明涉及这样的方法和系统，其中抗微生物润滑剂被涂布于导管装置的外表面以预防感染。
导管普遍用于多种输注治疗。例如，导管用于向患者输注流体，例如生理盐水溶液、多种药物和全胃肠外营养；用于从患者取血，以及用于监视患者血管系统的多项参数。
导管通常被导入患者的脉管系统(vasculature)，作为静脉内导管组件的一部分。导管组件一般包括导管接头，导管接头支撑导管，导管接头与针接口(needle hub)相连，针接口支撑导引针(introducer needle)。导引针延伸并被置于导管内，从而使得针的有斜面的部分暴露在导管尖端之外。针的有斜面的部分用于刺入患者的皮肤以提供开口，在该开口处针被插入患者的脉管系统。插入并安置了导管之后，从导管除掉导引针，从而提供向患者静脉内的接入。
导管相关的血流感染是由于微生物在具有血管内导管和静脉内接入装置的患者中的定殖(colonization)而引起的。这些感染是疾病和多余的医疗花费的重要诱因，每年在美国重症加护病房中发生大约250.000例导管相关的血流感染。除了金钱上的花费以外，无论何处每年与这些感染相关的死亡有20,000至100,000例。
虽然有辅助减少护理相关的感染(healthcare associated infections，HAI)的指南，但是导管相关的血流感染持续折磨着我们的护理系统。10种最常见的病原体(造成84％的HAI的任意种)是：凝固酶阴性葡萄球菌(15％)、金黄色葡萄球菌(Staphylococcusaureus)(15％)、肠球菌属(Enterococcus)的种类(12％)、假丝酵母属(Candida)的种类(11％)、大肠杆菌(Escherichia coli)(10％)、铜绿假单胞菌(Pseudomonas aeruginosa)(8％)、肺炎克雷白氏杆菌(Klebsiella pneumoniae)(6％)、肠杆菌属(Enterobacter)的种类(5％)、鲍氏不动杆菌(Acinetobacter baumannii)(3％)和奥克西托克雷白杆菌(Klebsiella oxytoca)(2％)。对于一些病原体-抗微生物剂组合而言，对于抗微生物剂有抗性的致病分离体的集合平均比例在HAI的类型之间有显著性不同。在所有的HAI中，有多达16％与下列多重抗药性病原体相关：甲氧西林抗性的金黄色葡萄球菌(HAI的8％)、万古霉素抗性的屎肠球菌(Enterococcus faecium)(4％)、碳青霉烯抗性的铜绿假单胞菌(2％)、超广谱的(extended-spectrum)头孢菌素抗性的肺炎克雷白氏杆菌(1％)、超广谱的头孢菌素抗性的大肠杆菌(0.5％)和碳青霉烯抗性鲍曼不动杆菌、肺炎克雷白氏杆菌(K.pneumoniae)、奥克西托克雷白杆菌(K.oxytoca)和大肠杆菌(0.5％)抗微生物剂抗性病原体。
具有多种抗微生物剂的浸渍导管(Impregnating catheters)是已被用于预防这些感染的一种方法。然而，这些导管产生的效果低于令人满意的效果。例如，这些导管在预防导管组件(catheter assembly)内表面和成分上的病原体生长和定殖方面显然无效。另外，一些微生物已经产生了对于该系统中的多种抗微生物剂的抗性。
因此，本领域需要具有改进的抗微生物能力的皮肤侵入性装置。本文公开了此类方法和系统。
发明概述
为了克服上述局限，本发明涉及涂布于导管装置的抗微生物润滑剂基质(matrix)，使得在导管装置完全插入患者时，抗微生物润滑剂被插入到导管与患者的真皮层之间。
在一些实施方式中，提供了抗微生物制剂作为不溶性润滑剂材料，其被涂布于导引针的外表面作为静脉内导管组件的组成部分。涂布润滑剂材料，使得当通过导管组件的血液控制隔膜抽出针时，隔膜的缝隙“涂刷(squeegee)”，或者以其他方式从针的外表面上除去部分润滑剂材料。除去的润滑剂材料集合在隔膜的膜和缝隙上，从而在缝隙与患者的脉管系统之间提供物理屏障。在一些情况中，部分除去的润滑剂材料沉积在缝隙内，由此进一步封闭或密封缝隙。
在一些情况中，润滑剂材料进一步包括润滑剂。该润滑剂减少缝隙与针外表面之间的摩擦。照此，以平滑和连续的方式通过隔膜上取出针，而不会污染或以其他方式损害隔膜缝隙。润滑剂材料的润滑剂还可以减少隔膜与通过缝隙插入的外部Luer装置之间的摩擦。抗微生物润滑剂可以被转至Luer装置，因为它通过缝隙插入，由此杀灭其上存在的任何病原体。在一些实施方式中，抗微生物润滑剂还包括抗血栓形成剂以减少血块存在于导管组件内的可能性。
附图说明
为了容易地理解获得本发明的上述和其它特征和优点的方式，将通过参考如附图诠释的具体实施方式来呈现上文简要描述的本发明的更具体的描述。这些附图仅显示了本发明的典型的实施方式，因此不被认为是限制本发明的范围。
图1是根据本发明的代表性实施方式的从导管接头中抽出前放置的具有涂敷的导引针的导管组件的横截面视图。
图2是根据本发明的代表性实施方式的从导管中部分抽出的具有涂敷的导引针的导管组件的横截面视图，其中通过血液控制隔膜已经从导引针中部分除去了导引针上的抗微生物润滑剂。
图3是根据本发明的代表性实施方式的具有涂敷了抗微生物材料的血液控制隔膜的导管组件的横截面视图，在从导管接头中抽出导引针时，通过血液控制隔膜从导引针的外表面上除去了所述抗微生物材料。
图4是根据本发明的代表性实施方式的除去导引针后血液控制隔膜和沉积的抗微生物润滑剂材料的横截面视图。
图5是根据本发明的代表性实施方式的除去导引针后血液控制隔膜中的缝隙的横截面视图，其中残留的抗微生物润滑剂材料沉积在血液控制隔膜缝隙内。
图6是显示根据本发明的代表性实施方式的用抗微生物组合物润滑隔膜的方法的流程图。
发明详述
通过参考附图将会最佳地理解本发明的目前优选的实施方式，其中相同的附图标记表示相同或功能相似的元件。将容易地理解：如本文附图所一般性描述和诠释的本发明的组件可以按照多种不同构型来排列和设计。因此，以下的如附图所代表的更加具体的描述不是意在限制所要求保护的本发明的范围，而是仅代表本发明的目前优选的实施方式。
现在来看图1，其显示了导管装置组件10。一般地，根据本发明的导管装置组件10提供向患者的脉管系统的接入，例如用于输注疗法或采血。在一些实施方式中，导管装置系统10包括导管接头30，其支撑导管管体40。导管管体40从导管接头30向外延伸并与之流体连通(fluid communication)。
在一些实施方式中，导管装置系统10还包括针接口(未显示)，其支撑导引针50。导引针50通过导管接头30和导管管体40螺纹地安置，从而针50的有斜面的尖端52延伸超出导管尖端42。有斜面的尖端52提供了切面，从而刺入患者的皮肤，并且提供了向患者的脉管系统的接入。一旦导管40被完全插入患者，则导引针50将被除掉，从而提供经由导管40和导管接头30向患者的静脉内接入。
在一些实施方式中，导管接头30还包括血液控制隔膜20。提供血液控制隔膜20作为物理屏障以控制导管接头30的向前的室32与向后的室34之间的血流和其它流体。例如，在有斜面的尖端52和导管尖端42插入患者静脉并且取出导引针50时，来自患者的血液流过导管管体40的腔44并且进入向前的室32。防止患者血流绕过隔膜20，由此将血液保留在向前的室32中。如果血液控制隔膜20未就位，则血液流入向后的室34并且以不受控制的方式脱离开口36。这可以导致不需要的使用者接触后者血液。因此，血液控制隔膜20被置于导管接头30的流体通道38中以防止使用者接触患者血液。
在一些情况中，血液控制隔膜20被固定进入提供在导管接头30的内表面33上的环状沟31。在一些实施方式中，血液控制隔膜20包括大于流体通道38的内径的外径，并且稍大于环状沟31的直径。因此，血液控制隔膜20被固定进入环状沟31且防止在近端12和远端14方向上的流体通道38内流动。在其它情况中，血液控制隔膜20的外周边缘通过粘合剂、塑料连接物或其它机械连接方式(例如固定夹(retainer clip))与内表面33固定。
血液控制隔膜20可以包括任意结构构造，其能够将流体通道38分成向前和向后的室32和34。例如，在一些实施方式中，血液控制隔膜20包括盘。在其它实施方式中，血液控制隔膜20包括具有近端开口22和形成远端帽的膜24的圆柱形物。在一些实施方式中，膜24包括缝隙26或多个形成通过膜24的通道的缝隙。缝隙26可以被配置成允许导引针50通过隔膜20。
隔膜20的回弹或伸长属性允许缝隙26伸长且由此容纳导引针50通过。在一些情况中，缝隙26与导引针50的外表面之间的密封物或界面足够紧密，以便当在近端方向12上移动导引针50时，缝隙26防止流体从向前的室32通过至向后的室34。此外，当导引针50沿近端方向12经过缝隙26时，存在于位于向前的室32的部分导引针50的外表面54上的血液从外表面54上被除去或“涂刷”。在从缝隙26中完全取出导引针50时，缝隙26自我封闭，由此进一步防止向前的室32内的流体从通道进入向后的室34。
典型地，用有助于在取出导引针过程减少系统阻力的油状润滑剂涂敷导引针50。在一些实施方式中，所述润滑剂还包括形成抗微生物润滑剂60的抗微生物剂。提供所述抗微生物润滑剂60作为防止微生物和病原体在导管组件10内定殖和生长的用品(means)。在一些实施方式中，将所述抗微生物润滑剂60涂布于导引针50的整个外表面54上。在一些情况中，将所述抗微生物润滑剂60涂布于位于向前的室32的外表面54部分上。在临床应用过程中，如果从导管中取出导引针，则在导引针50沿近端12的方向通过缝隙26移动时，部分抗微生物润滑剂60从外表面54中被除去或“涂刷”，从而在隔膜表面上和缝隙26内形成抗微生物屏障。按照这种方式，抗微生物润滑剂60作为屏障起作用以防止细菌污染导管内的流体。
在一些实施方式中，抗微生物润滑剂不溶于大部分输注液且在多次操作例如抽血、药物输注、TPN操作过程中，血液由此停留在隔膜表面上以及盐水和肝素冲洗液(heparin flushes)。因此，抗微生物润滑剂可以提供长效抗微生物防护作用。
在本发明中润滑剂的制剂由一种或多种润滑剂组合和抗微生物剂的混合物组成。在该混合物中，所述抗微生物剂均匀和持久地遍在分布于润滑剂基质中。
在一些实施方式中，抗微生物润滑剂60包括水溶性润滑剂、不溶性润滑剂、粘性凝胶润滑剂、固体润滑剂和可成形的润滑剂的至少一种。
在一些实施方式中，抗微生物润滑剂60包括油润滑剂。所述油润滑剂可以是聚二甲基硅氧烷、聚三氟丙基甲基硅氧烷或二甲基硅氧烷和三氟丙基甲基硅氧烷的共聚物。所述油润滑剂的粘度可以为20cp-1,000,000cp。在一些实施方式中，将溶剂加入到具有极高粘度的油润滑剂中以有利于所述抗微生物润滑剂涂布。
可以通过浸渍、涂刷、喷雾或任意其它本领域公知的相容性技术将抗微生物润滑剂60涂布于外表面54。在一些实施方式中，将过量的抗微生物润滑剂60涂布于外表面54，然后将导引针50装配入导管组件10。通过隔膜20插入导引针50并且通过提供经隔膜20的扩展的通道将其插入导管40。按照这种方式，抗微生物润滑剂60不会在装配过程中从外表面54中移动。
例如，在一些实施方式中，将穿线器(未显示)插入开口36并且通过隔膜的缝隙26以偏压(bias)缝隙26而进入扩展的开放的位置。缝隙26的扩展的开放的位置一般大于导引针50的涂敷部分的直径。导引针50的涂敷部分经缝隙26通过穿线器通过，且通过导管40的腔44向前移动，直到有斜面的尖端42延伸超过导管尖端52。一旦就位，则从缝隙26和导管接头30中取出穿线器。隔膜20的回弹属性允许缝隙26重新恢复其围绕外表面54的封闭位置。
抗微生物润滑剂60一般包括有效抵抗可能在患者中引起感染的细菌的多种形式和菌株的抗微生物剂或杀生物剂。如本文使用的术语“杀生物试剂”或“杀生物剂”是指破坏、抑制和/或防止不需要的生物的繁殖、生长、定殖和复制的活性剂。术语“生物”包括但不限于微生物、细菌、波形细菌(undulating bacteria)、螺旋菌、孢子、孢子形成性生物、革兰氏阴性生物、革兰氏阳性生物、酵母、真菌、霉菌、病毒、需氧生物、厌氧生物和分支杆菌。此类生物的具体实例包括真菌：黑曲霉(Aspergillus niger)、黄曲霉(Aspergillusflavus)、黑根霉(Rhizopus nigricans)、分支孢子菌(Cladosprorium herbarium)、絮状表皮癣菌(Epidermophyton floccosum)、须疮癣菌(Trichophyton mentagrophytes)、荚膜组织胞浆菌(Histoplasma capsulatum)等；细菌：例如铜绿假单孢菌(Pseudomanasaeruginosa)、大肠杆菌、普通变形杆菌(Proteus vulgaris)、金黄色葡萄球菌(Staphylococcus aureus)、表皮葡萄球菌(Staphylococcus epidermis)、粪链球菌(Streptococcus faecalis)、克雷伯菌属(Klebsiella)、产气肠杆菌(Enterobacteraerogenes)、奇异变形杆菌(Proteus mirabilis)，其它革兰氏阴性细菌和其它革兰氏阳性细菌、分支杆菌等；酵母：例如酿酒酵母(Saccharomcyces cerevisiae)、白色念珠菌(Candida albicans)等。另外，微生物的孢子、病毒等也是本发明的范围内的生物。
适合用于本发明的抗微生物剂或杀生物剂包括但不限于苯酚、季铵、胍、牛磺罗定、对氯间二甲酚、磺胺嘧啶银、氧化银、硝酸银、吡啶鎓、苯扎氯铵、西三溴胺、苄索氯铵(benethonium chloride)、西吡氯铵、醋酸克菌定、地喹氯铵和氯二甲酚。此外，在一些实施方式中，涂层60包括选自下列的杀生物试剂：氯己定碱、葡萄糖酸氯己定、醋酸氯己定、盐酸氯己定(chlorhexidine hydrochloride)、二盐酸氯己定(chlorhexidinedihydrochloride)、双溴丙脒、卤化二苯烷胺类、二苯脲、水杨苯胺、四氯水杨酰苯胺、三氯碳酰苯胺及其混合物。此外，在一些实施方式中，润滑剂60包括选自下列的杀微生物剂：二盐酸氯己定、葡萄糖酸氯己定、醋酸氯己定、二乙酸氯己定(chlorhexidine diacetate)、三氯生、氯二甲酚、地喹氯铵、苄索氯铵、苯扎氯铵及其组合。所述抗微生物剂可以是不溶于所述润滑剂的固体颗粒或液体形式。可以将所述抗微生物剂在所述润滑剂中充分混合，然后涂布于引导针上。
在一些实施方式中，润滑剂60包括用量为润滑剂60的约0.01％(w/v)-约10.0％(w/v)的一种或多种抗微生物生物剂。在其它实施方式中，润滑剂60包括用量为润滑剂70的约0.001％(w/v)-约5.0％(w/v)的一种或多种抗微生物剂。此外，在一些实施方式中，润滑剂60包括用量为约0.01％-约10.0％(w/v)的一种或多种抗微生物剂。
在一些实施方式中，润滑剂60还包括一种或多种挥发性溶剂，例如四氢呋喃(THF)、甲基乙基酮(MEK)和己烷溶剂。在一些实施方式中，润滑剂60包括约等于70％(w/v)的润滑剂60的用量的挥发性溶剂。在其它实施方式中，润滑剂60包括两种或更多种挥发性溶剂。
在其它实施方式中，润滑剂60包括一种或多种醇成分。适合的醇成分一般包括具有1-6个碳(C1-C6)的低级醇。在一些实施方式中，润滑剂60包括选自乙醇、异丙醇、丙醇和丁醇的醇成分。在其它实施方式中，润滑剂60包括两种或更多种低级醇成分，例如约1：10-约1：1比例的异丙醇和乙醇的混合物。此外，在一些实施方式中，润滑剂70包括超过两种醇成分的混合物。
在一些实施方式中，润滑剂60包括约等于40％(w/v)的润滑剂60的用量的醇成分。在其它实施方式中，润滑剂60包括约20％(w/v)-约95％(w/v)的用量的醇成分。
在一些实施方式中，抗微生物润滑剂60还包括润滑剂，例如硅油。在一些实施方式中，给导引针50涂敷高粘度抗微生物润滑剂60以减少导引针50与导管尖端42之间的粘附以及导引针50与隔膜20之间的粘附。在从导管40和隔膜20中抽出导引针50时，隔膜20的缝隙26可以抵抗导引针50的外表面54的摩擦，由此除去过量的润滑剂60，如图2中所示。
在一些实施方式中，抗微生物润滑剂60还包括抗血栓形成剂。提供抗血栓形成剂是为了减少导管组件10内血液凝块的可能性。在一些情况中，提供抗血栓形成剂是为了减少向前的室32内或抗微生物润滑剂60涂敷的任意表面上血液凝块的可能性。
现在来看图2，显示具有部分抽出的导引针50的导管组件10。在一些实施方式中，当沿近端方向12通过隔膜20的缝隙26抽出导引针50时，过量的抗微生物润滑剂60被“涂刷”或从外表面54上除去。过量的润滑剂60集合在向前的室32内，由此提供膜24与向前的室32之间的屏障。该屏障会杀伤接触和/或接近润滑剂的微生物，从而防止微生物在膜24上且一般是在向前的室32内的生长和定殖。
在从隔膜20中完全抽出导引针50时，缝隙26自我封闭，由此进一步提供向前的室与向后的室32与34之间的屏障，如图3中所示。过量抗微生物润滑剂60提供的屏障可以进一步迁移至接近隔膜的另外的表面，由此提供对超过隔膜的导管的内表面的抗微生物防护作用。
在一些实施方式中，血液控制隔膜20的缝隙26包括三重-缝隙构造。如图4中所示。在取出导引针50后，过量的抗微生物润滑剂60沉积在膜24上，由此覆盖缝隙26。抗微生物润滑剂60防止病原体在膜24上定殖和生长。
在一些实施方式中，过量的抗微生物润滑剂60迁移进入缝隙26，由此填充缝隙26中的任意空隙或开口，如图5中所示。按照这种方式，过量的抗微生物润滑剂60有助于隔膜20防止流体在向前的室与向后的室32与34之间流动。
本发明的一些实施方式还包括用抗微生物引针润滑油润滑血液控制导管的隔膜的方法，如图6中所概括的。在一些情况中，第一步润滑隔膜包括将抗微生物润滑剂涂布于导引针的外表面(在步骤100时)。然后将涂敷的导引针通过安置在导管组件内的隔膜的缝隙插入(在步骤200时)。在一些情况中，首先将穿线器插入隔膜的缝隙以提供扩展的开口。按照这种方式，防止所述抗微生物润滑剂在装置装配过程中移动。一旦在导管组件内就位，则从缝隙中取出穿线器且该装置处于备用状态。
当从隔膜和导管组件装置中抽出导引针时，涂敷隔膜(在步骤300时)。当抽出导引针时，隔膜的缝隙涂刷过量的来自针外表面的抗微生物润滑剂。这种过量的抗微生物润滑剂沉积在膜和隔膜的缝隙部分上。在一些情况中，过量的抗微生物润滑剂沉积在导管组件装置的向前的室内，以便在隔膜与患者脉管系统之间形成另外的屏障。
可以不脱离如本文广泛描述和随后要求保护的结构、方法或其它必要特征而以其它具体形式实施本发明。例如，本发明可以应用于任何皮肤侵入性装置，例如针、解剖刀、套针、内诊镜、造口器具(stoma appliance)等。所描述的实施方式被认为在所有方面都是示例性的而非限制性的。因此，本发明的范围由随附的权利要求确定，而不是由上述说明书确定。在权利要求的等同意义和范围内的所有变化都包括在其范围内。

Claims (19)

1.导管组件，包括：
具有近端、远端和在它们之间延伸的流体通道的导管接头；
具有远端和近端的导管，该导管的近端连接至导管接头的远端，该导管具有与流体通道流体连通的腔；
配置在流体通道内的隔膜，由此将流体通道分隔成向前的室和向后的室，该隔膜具有缝隙；
具有基底、尖端和在它们之间延伸的主体的针，当针延伸超过导管的远端时，一定量的抗微生物润滑剂涂布于针的远离隔膜的远端的主体外表面的至少一部分上，其中当针延伸超过导管的远端时，该一定量的抗微生物润滑剂与导管和导管接头间隔开，其中当针通过隔膜的缝隙向近端抽出时，隔膜从针上除去抗微生物润滑剂，从而在隔膜的远侧上沉积抗微生物润滑剂。
2.根据权利要求1所述的导管组件，其中所述缝隙包括三重-缝隙构造。
3.根据权利要求1所述的导管组件，其中所述抗微生物润滑剂包括水溶性润滑剂、不溶性润滑剂、粘性凝胶润滑剂、或固体润滑剂的至少一种。
4.根据权利要求1所述的导管组件，其中所述抗微生物润滑剂包括油润滑剂。
5.根据权利要求1所述的导管组件，其中所述抗微生物润滑剂包括抗微生物剂。
6.根据权利要求5所述的导管组件，其中所述抗微生物剂是二盐酸氯己定、葡萄糖酸氯己定、醋酸氯己定、二乙酸氯己定、三氯生、氯二甲酚、地喹氯铵、苄索氯铵和苯扎氯铵的至少一种。
7.根据权利要求5所述的导管组件，其中所述抗微生物润滑剂还包括挥发性溶剂成分、醇成分、聚合物成分和抗微生物剂的至少一种。
8.根据权利要求5所述的导管组件，其中所述抗微生物剂是不基于醇的抗微生物剂。
9.根据权利要求7所述的导管组件，其中所述抗微生物润滑剂不溶于水。
10.根据权利要求7所述的导管组件，其中所述抗微生物润滑剂是水溶性的。
11.根据权利要求7所述的导管组件，其中所述抗微生物剂的存在量为0.001％(w/v)-10.0％(w/v)。
12.根据权利要求7所述的导管组件，其中所述抗微生物剂是盐酸氯己定、葡萄糖酸氯己定、醋酸氯己定、二乙酸氯己定、三氯生、氯二甲酚、地喹氯铵、苄索氯铵和苯扎氯铵的至少一种。
13.根据权利要求7所述的导管组件，其中所述醇成分包括具有1-6个碳原子的低级醇。
14.根据权利要求7所述的导管组件，其中所述醇成分以等于20％(w/v)的量存在于所述抗微生物润滑剂中。
15.根据权利要求7所述的导管组件，其中所述醇成分包括异丙醇和乙醇的混合物，并且以40％(w/v)-95％(w/v)的量存在于所述抗微生物润滑剂中。
16.根据权利要求7所述的导管组件，其中所述抗微生物润滑剂包括醇成分，其以20％(w/v)-95％(w/v)的量存在于所述抗微生物润滑剂中。
17.将抗微生物润滑剂涂布于导管组件的隔膜的远端表面上的方法，该方法包括：
将针放置在隔膜的缝隙内，使得针的远端部分被安置成远离隔膜并且针的近端部分被安置成接近隔膜；
将抗微生物润滑剂涂布于针的远端部分的外表面上，其中抗微生物润滑剂是收集在导管组件的向前的室内的过量的润滑剂；和
在近端方向上从隔膜的缝隙中抽出针，使得当针穿过隔膜的缝隙时，缝隙从针的远端部分的外表面上除去部分抗微生物润滑剂，从而在隔膜上与缝隙邻近的位置形成所述抗微生物润滑剂沉积物。
18.根据权利要求17所述的方法，其中所述缝隙包括三重-缝隙构造。
19.根据权利要求17所述的方法，其中所述抗微生物润滑剂包括水溶性润滑剂、不溶性润滑剂、粘性凝胶润滑剂和固体润滑剂的至少一种。
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