CN204972644U - 导管组件 - Google Patents
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- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/10—Tube connectors; Tube couplings
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Abstract
本申请公开了一种导管组件(100)，该导管组件包括导管适配器(120)，导管适配器具有近端开口、远端和在所述近端开口和远端之间延伸的流体通路，所述导管适配器的远端容纳导管(50)；可滑动地设置在所述流体通路(26)中的间隔件(40)，所述间隔件将所述流体通路划分为近端流体腔室(146)和远端流体腔室(148)；间隔件促动器(20)，该间隔件促动器固定定位在所述远端流体腔室中且具有探头表面，该探头表面配置成当间隔件在流体通路内朝向导管适配器的远端推进时将间隔件偏置到打开位置。
Description
技术领域
本申请涉及一种医疗装置，尤其是带有固定式间隔件促动器的导管组件。
背景技术
本发明涉及具有集成的、固定式间隔件促动器的血液控制静脉(IV)导管。此外，本发明涉及对血液控制静脉导管的各表面涂覆抗病原材料的系统和方法。此外，本发明涉及对血液控制静脉导管的导管适配器、固定式间隔件促动器和血液控制间隔件之间的各相接表面涂覆抗病原润滑剂材料以减少它们之间的摩擦的系统和方法。
现在医疗的巨大挑战是在致病生物扩散时控制感染。持续存在该挑战的一个领域是各种类型的输注疗法。输注疗法是最常见的健康护理程序之一。住院患者、在家护理的患者和其他患者通过插入患者血管系统的血管接入装置来接收流体、药剂和血液产品。输注疗法可用来治疗感染，提供麻醉或镇痛，提供营养支持，治疗癌性生长，维持血压和心脏节律，或者许多其他临床上重要的用途。
通过血管接入装置使输注疗法更便利。血管接入装置可以接入患者的外周或中央脉管。血管接入装置可以短期(数天)、中期(数周)或长期(数月，两年)留置。血管接入装置可用于连续输注疗法或用于间断性疗法。
常见的血管接入装置包括插入患者静脉中的塑料导管。导管长度可从用于外周接入的几厘米变化到用于中央接入的很多厘米，并且可以包括诸如外周插入中央导管(PICC)的装置。导管可以经皮插入或者可以通过手术方式植入到患者皮肤之下。导管或者任何其他与之附接的血管接入装置可具有单个管腔或者用于同时输注多种流体的多个管腔。
常见的血管接入装置包括控制血液和其他流体流经血管接入装置的血液控制间隔件。在一些实例中，血管接入装置还包括可滑动地容纳在血管接入装置内的间隔件促动器。间隔件促动器可以前进穿过血液控制间隔件以使血液或其他流体绕过间隔件。通常地，通过提供间隔件促动器能够在其中滑动的通道或其他结构，间隔件促动器被保持在血管接入装置内。这些结构要求精密加工以实现利于间隔件促动器在血管接入装置内适当滑动运动所要求的关键尺寸。
血管接入装置会作为病灶而导致散播的BSI(血流感染)。这可能是由于未能规律地清洗装置、未消毒插入技术，或者由于在导管插入后通过通路的任一端进入流体通路的病原体导致的。当血管接入装置被污染时，病原体附着在血管接入装置上，移生，并且形成生物膜。生物膜对许多杀菌剂具有耐受力，并且提供进入患者血流而导致BSI的补充病原体源，导致BSI。
一种防止生物膜形成和患者感染的方法是在各种医疗装置和部件上提供抗病原涂层。然而，一些医疗装置和部件包括与抗病原涂层不相容的材料或特征。因此，虽然存在用于控制血流通过血管接入装置以及用于提供抗病原涂层的方法，仍存在挑战。因此，扩充当前技术或者甚至用其他技术来替代当前技术将是本领域的改进。在本文中公开了这样的技术。
实用新型内容
为了克服上述局限性，本发明涉及作为输注疗法一部分的、对医疗装置的接触血液或其他流体的非关键尺寸表面进行选择性涂覆的系统和方法。
根据本发明的一个方面，提供了一种导管组件，所述导管组件包括：导管适配器，所述导管适配器具有近端开口、远端和在所述近端开口与所述远端之间延伸的流体通路，所述导管适配器的远端容纳导管；间隔件，所述间隔件可滑动地布置在所述流体通路内，所述间隔件将所述流体通路划分成近端流体腔室和远端流体腔室；以及间隔件促动器，所述间隔件促动器固定定位在所述远端流体腔室内且具有探头表面，所述探头表面配置成当所述间隔件在所述流体通路内朝向所述导管适配器的远端前进时将所述间隔件偏置到打开位置。
本发明的一些实施方式包括输注疗法医疗装置，诸如导管组件，其具有可滑动地容纳在导管适配器的流体通路内的血液控制间隔件。血液控制间隔件被构造为在导管适配器内沿远端方向和近端方向滑动。导管适配器还包括在固定位置处紧固到导管适配器的内表面上的间隔件促动器。间隔件促动器包括探头部，该探头部在接近血液控制间隔件的位置处同心地或沿轴向定位在导管适配器的流体通路内。随着血液控制间隔件沿远端方向滑动，间隔件促动器的探头部前进穿过血液控制间隔件，以提供通过间隔件的通路。在释放血液控制间隔件时，间隔件沿近端方向滑动，使得间隔件促动器的探头部从血液控制间隔件移除。因此，通过血液控制间隔件的通路闭合，以防止流体通过导管适配器的流体通路继续流动。
在一些实例中，间隔件促动器包括导管适配器的内表面的模制结构。在其他实例中，间隔件促动器包括固定地耦接到导管适配器的内表面的独立单元。此外，在一些实例中，间隔件促动器包括导管楔形件，其中间隔件促动器将导管的基部紧固到导管适配器上，间隔件促动器的探头部沿近端方向从导管楔形件向外延伸。本发明的间隔件促动器还包括管腔，当间隔件促动器前进通过血液控制间隔件时，该管腔与导管适配器的流体通路流体连通。因此，流体可以流经导管适配器的流体通路且经由间隔件促动器的管腔进入导管。
在一些实例中，抗病原材料施加到导管组件的各表面上，以防止病原体在装置的流体通路内移生。在其他实例中，抗病原材料还包括减小导管组件的各部件之间摩擦的润滑剂。
本发明的导管组件的一些表面可包括非关键尺寸，其中抗病原材料施加到这类表面上。这一些实例中，抗病原材料施加到还包括通过装置的流体通路一部分的一个或多个表面上。因此，抗病原材料暴露于流经装置流体通路的流体之下。
在一些实例中，提供了一种输注疗法医疗装置，其具有间隔件促动器，该间隔件促动器包括探头部，该探头部被构造成在间隔件促动器促动时前进通过装置的间隔件。在一些实施方式中，包括润滑剂的抗病原材料施加到间隔件促动器的探头部上，以在装置促动期间减小间隔件促动器与间隔件之间的摩擦。在其他实施方式中，刚性或半刚性的抗病原材料被施加到间隔件促动器基部的各个表面上。
本发明的一些方案还包括色码系统，由此基于医疗装置的颜色来识别抗病原材料的特性。
本发明的一些方案包括具有相容表面的医疗装置，该相容表面包括至少一种机械接合，由此利于表面与抗病原材料之间的结合。本发明的其他方案包括：通过表面交联来提供医疗装置的相容表面与抗病原材料之间的化学键合。
本发明还包括用于识别和涂覆包含非关键尺寸的医疗装置表面的各种方法、技术和材料。因此，抗病原材料可施加到医疗装置内的各个表面上以减小或消除病原在医疗装置内的移生和/或生长，从而降低患者病原感染的风险。
附图说明
为了易于理解获得本发明的上述以及其他特征和优点的方式，将参照具体实施例对上文所简述的发明做更为具体的描述，这些具体实施方案例示于附图中。这些附图仅描绘了本发明的典型实施方案，因此不应被视为是对本发明范围的限制。
图1是依照本发明的代表性实施例的导管组件在促动前的剖视侧视图，该导管组件包括集成的、固定式间隔件促动器。
图2是依照本发明的代表性实施例的导管组件的剖视侧视图，该导管组件包括经由环状槽与导管适配器固定耦接的间隔件促动器。
图3是依照本发明的代表性实施例的图1所示导管组件在促动之后的剖视侧视图。
图4是依照本发明的代表性实施例的导管组件的剖视侧视图，该导管组件包括间隔件促动器，该间隔件促动器具有远端，该远端具有楔形件，该楔形件被构造成将导管的基部固定耦接到导管适配器的远端中，所述间隔件促动器还包括探头，该探头从楔形件向远端延伸且位于导管组件的血液控制间隔件附近。
图5是依照本发明的代表性实施例的图4所示导管组件的分解剖视图。
图6是依照本发明的代表性实施例的图4所示导管组件在被鲁尔适配器促动之后的剖视侧视图。
图7是依照本发明的代表性实施例的血液控制间隔件的剖视侧视图，该血液控制间隔件具有施加到具有关键尺寸和非关键尺寸的各表面上的润滑的和非润滑的抗病原材料。
图8是依照本发明的代表性实施例的间隔件促动器的剖视图，该间隔件促动器具有远端，远端包括楔形件，楔形件被构造成将导管的基部固定耦接到导管适配器的远端中，间隔件促动器还包括探头，该探头从楔形件向远端延伸，从而位于导管组件的血液控制间隔件附近，所述间隔件促动器具有施加在具有关键尺寸和非关键尺寸的各表面上的润滑的和非润滑的材料。
具体实施方式
通过参考附图将最佳地理解本发明的当前优选的实施方案，其中相似的附图标记表示相同或功能上相似的元件。将易于理解的是，如在本文中概述的在图中图示的本发明的部件可以布置和设计成各种不同的构造。因此，附图中表示的以下更详细的说明无意限制权利要求所述的本发明范围，而仅代表了本发明的当前优选的实施方案。
术语“近端”用来表示装置在正常使用期间最靠近使用者且最远离患者的部分。术语“远端”用来表示装置在正常使用期间最远离使用装置的使用者且最靠近患者的部分。术语阀门机构或间隔件的“促动”用来表示这种阀门的打开或闭合动作。例如，在一些实施例中，提供了一种导管组件，其具有间隔件和间隔件促动器，其中当间隔件促动器前进通过间隔件时，导管组件经历促动，从而提供通过间隔件的流体通路。
术语“关键尺寸”用来表示对于装置的操作至关重要的医疗装置表面的高度、长度、宽度、深度、直径、厚度、角度、纹理、或其他结构特征中的至少一个。例如，在一些实施例中，医疗装置可以包括被构造为与另一装置或部件相接的表面。因此，该表面可以包括被配置为适应医疗装置的表面与相接装置或部件之间的最优互动的关键尺寸。因此，在一些实施例中，具有关键尺寸的表面必须保持不变，以便保留在操作或使用医疗装置时该表面的预期和/或期望的互动。相反地，术语“非关键尺寸”用来表示对于装置操作不重要的医疗装置的高度、长度、宽度、深度、直径、厚度、角度、纹理、或其他结构特征中的至少一个。
术语“化学键合”或“化学结合”用来表示允许将抗病原材料施加到医疗装置的期望表面上的原子之间的吸引。例如，在一些实例中，本发明的抗病原材料经由化学键合施加到输注疗法医疗装置的表面上，其中抗病原材料的原子和医疗装置的原子相互化学吸引。化学结合可包括任意类型的原子键，诸如共价键、离子键、偶极-偶极相互作用、伦敦分散力、范德瓦尔斯力和氢键合。对于一些实施例，化学键合可进一步由术语“交联”或“表面交联”来表示。
术语“机械接合”或“机械结合”用来表示两种或多种材料之间的物理的、非化学的相互作用。例如，在一些实例中，医疗装置的表面被改造成包括纹理、槽和/或具有空隙的脊状件，其经由毛细力来保持抗病原材料。在其他实施例中，机械接合包括为医疗装置的表面提供增加的表面积的结构特征。此外，在一些实施例中，机械接合包括施加到医疗装置的表面上以吸引抗病原材料的亲水或疏水材料或涂层。对于一些实施例，机械接合还可以由术语“机械互锁”来表示。
术语“相容表面”用来表示医疗装置的包括非关键尺寸的表面，或不会由于添加抗病原材料或涂层而受到不利影响的包括关键尺寸的表面。
术语“刚性”或“半刚性”用来表示抗病原材料的物理属性，其中材料缺乏柔性、或者没有或几乎没有柔性。可替代地，这些术语用来表示当施加到或涂覆到装置表面上时抗病原材料的非柔性或者几乎非柔性的物理属性。在一些实例中，术语“半刚性”应理解成描述了在某种程度上为刚性或者在一些部分中为刚性的抗病原材料的物理属性。
术语“调整流变学”用来表示抗病原材料的物理属性，其中抗病原材料的粘性经过调整，以防止当施加到装置的表面上时抗病原材料的过度迁移。因此，抗病原材料的调整流变学防止或基本上防止抗病原材料接触邻近的表面或部件。
术语“抗病原的”用来表示抵抗病原体的材料，如涂层材料。病原体可包括能够导致疾病的任何有机体或物质，例如细菌、病毒、原生动物和真菌。因此，在本文中预期的“抗病原材料”包括任何具有抵抗病原体属性的材料。
本发明涉及具有集成的、固定式间隔件促动器的血液控制静脉(IV)导管。此外，本发明涉及用于对血液控制静脉导管的各表面涂覆抗病原材料的系统和方法。此外，本发明涉及对血液控制静脉导管的导管适配器、固定式间隔件促动器和血液控制间隔件之间的各相接表面涂覆抗病原润滑剂材料以减小它们之间摩擦的系统和方法。
在一些实例中，抗病原材料施加到包括非关键尺寸的表面上。在一些实施例中，在组装医疗装置之前，抗病原材料施加到医疗装置的一个或多个表面上。在其他实施例中，抗病原材料施加到医疗装置的第一部分或部件上，随后通过抗病原材料的受控迁移转移到医疗装置的第二部分或部件上。在其他实例中，在装置成型过程中，抗病原材料与医疗装置的材料混合或者结合到医疗装置的材料中。此外，在一些实例中，抗病原材料施加到或结合到医疗装置的材料中，使得抗病原材料从医疗装置的材料中洗脱出来并进入经过涂层的医疗装置的直接环境中。例如，在一些实施例中，提供了血液控制静脉导管组件，其中润滑的和非润滑的抗病原材料被施加到导管组件的具有关键尺寸和非关键尺寸的表面上，如序号为13/471,716的美国专利申请中所教导的那样，该申请整体并入本文中。
一般地，根据本发明的抗病原材料可包括可施加到医疗装置表面上的、具有抗病原性质的任何材料。例如，在一些实施例中，抗病原材料可包括抗菌成分，如序号为12/397,760、11/829,010、12/476,997、12/490,235和12/831,880的美国专利申请中所教导的那样，以上各申请均通过引用而整体并入本文中。在一些实施例中，抗病原材料还可以包括抗感染或抗菌润滑剂，如序号为12/436,404和12/561,863的美国专利申请所教导的那样，以上各申请整体并入本文中。此外，在一些实施例中，抗病原材料结合到例如间隔件促动器的医疗装置或其部件的材料中。
本发明的一些实施例包括一种医疗装置或部件，所述医疗装置或部件具有限定通过该医疗装置的一部分流体通路的至少一个表面。医疗装置的表面涂覆有抗病原材料，以防止病原体在涂层表面上移生。
抗病原材料施加到医疗装置的表面上使得将抗病原材料层或“涂层”添加到表面上。这层抗病原材料具有的尺寸(即，厚度)会影响涂层表面与医疗装置的接口或邻近部件之间的关系。例如，在一些实施例中，医疗装置可以包括孔口，该孔口具有通过例如摩擦、按压或机械配合或过盈配合来相容地接纳第二医疗装置的直径。因此，孔口的直径包括确保孔口与第二医疗装置之间正确装配的关键尺寸。在该示例中，抗病原材料添加到孔口的表面将调节孔口的直径，从而不利地影响孔口接纳第二医疗装置的能力。
因此，在本发明的一些实施例中，不期望对医疗装置或部件的表面进行调整或涂覆，其中所述表面包括将会受到抗病原材料添加不利影响的关键尺寸。因此，本发明的一些实施例包括对医疗装置涂覆抗病原材料的方法，其中该方法包括第一步，即识别医疗装置的包括非关键尺寸的表面。该方法还可以包括如下步骤：然后，用抗病原材料涂覆具有非关键尺寸的表面。本发明的一些方法还可以包括如下步骤：在为其余表面涂覆抗病原材料之前，识别和隔离医疗装置的具有关键尺寸的表面。
现在参考图1，示出了血液控制导管组件10。一般地，血液控制导管组件10包括导管适配器20，导管适配器20具有近端22、远端24和在近端22与远端24之间延伸的流体通路26。在一些实例中，近端22包括用于将外部装置与导管适配器20耦接的结构。例如，在一些实施例中，近端22包括一组螺纹，以相容地接纳鲁尔适配器。
导管适配器20大致具有管状形状。内表面28朝向远端24渐缩，具有逐渐减小的直径。导管适配器20优选由透明或半透膜材料制成，从而显示出内部，从而能够查看内部的运动。用于导管适配器20的适合的材料包括但不限于热塑性聚合树脂，诸如聚碳酸酯、聚苯乙烯、聚丙烯等。
导管组件10还包括导管50。导管50的基部52插入远端24的开口中且经由压配合的楔形件60紧固。在一些实施例中，优选的是润滑涂层设在导管50的外表面上，以减小由于通过皮肤插入或者插入血管所引起的阻力。用于导管50的适合的材料包括但不限于诸如氟化乙丙烯(FEP)、聚四氟乙烯(PTFE)、聚氨酯等热塑性树脂。在一些实施例中，导管40由在暴露于患者体中存在的生理条件下软化的热塑性亲水聚氨酯形成。
导管组件10还可以包括与套管针导管组件一起使用的结构。例如，柔性的或半柔性的聚合物导管可与刚性导入针相结合使用，以便能够将导管插入患者的血管中。还可以使用通过手术方式植入的导管。
正如期望的输注程序所要求的，一旦插入患者体中，导管50和导管适配器20提供流体管道，以利于将流体输送到患者体中和/或从患者体中抽取流体。因此，在一些实施例中，选择导管50和导管适配器20的材料，以使其与在输注操作中常用的生物流体和药剂相容。另外，在一些实施例中，导管50和/或导管适配器20的一部分被构造为与静脉管道(未显示)的一段联用，以进一步利于将流体输送到患者体中或者从患者体中移除流体。
导管适配器20还包括间隔件促动器30。间隔件促动器30固定地紧固在流体通路26内，并且定位成使得血液控制间隔件40可以在流体通路26内沿远端方向14滑动并被间隔件促动器30偏置到打开位置。在一些实例中，间隔件促动器包括导管适配器20的模制内部结构。例如，间隔件促动器20可以包括基部34，其熔合到内表面28或者形成为内表面28的部分。可替代地，间隔件促动器20可以包括具有基部34的独立单元，该基部34固定地紧固在内表面28的环状槽29内，如图2所示。
继续参考图1和图2，间隔件促动器20还包括从基部34向近端延伸的探头部32。探头部32在流体通路26内大体沿轴向居中布置。选择探头部32与基部34之间的距离，以允许间隔件40在间隔件促动器30上不受阻碍地向前或向远端运动。在一些实例中，选择探头部32与底座34之间的距离，以限制间隔件40在流体通路26内的向前运动，从而防止探头部32穿过间隔件40的狭缝42过度贯穿。
间隔件促动器30为大体管状且包括与流体通路26流体连通的管腔36。在一些实例中，血液控制间隔件40包括前向插座44和后向插座46，其中前向插座和后向插座被包括狭缝42的膜48分开。前向插座44一般包括被配置为接收和容纳间隔件促动器30的探头部32的内径和长度。因此，当间隔件40的狭缝42被偏置到打开位置时，流体可以在管腔36、流体通路26与导管50之间自由地流动。
在间隔件40促动之前，探头部32位于前向插座44内，位于接近膜48的位置。随着间隔件40在流体通路26内沿远端方向14滑过探头部32，间隔件40的狭缝42被偏置到打开位置。在一些实例中，随着外部装置12在近端22插入流体通路26中，间隔件40沿远端方向14前进，如图3所示。
继续参考图3，随着外部装置12插入导管适配器20的近端22，间隔件40在流体通路26内向远端滑动且重新定位。外部装置12的接触表面13插入近端22中以接触间隔件40的近端表面49。随着接触表面13前进到流体通路26中，间隔件40沿远端方向14滑动，从而使间隔件40滑过间隔件促动器30的探头部32。探头部32将狭缝42偏置到打开位置，从而提供导管50、管腔36、后向插座46、流体通路26与外部装置12之间的流体连通。在移除外部装置12时，间隔件40的回弹特性导致狭缝42的自主闭合，从而使间隔件40沿近端方向16滑动到其初始的起始位置。
在一些实施例中，探头部32包括渐缩的外表面，该减缩的外表面利于在去除外部装置12之后使狭缝42闭合以及间隔件40沿近端方向16退回。在其他实施例中，导管适配器20的内表面28包括限制或抑制间隔件40向远端移动的一个或多个表面结构。例如，在一些实施例中，内表面28包括随着间隔件40沿远端方向14前进而压缩间隔件40外表面的缩减的直径54。在移除外部装置12之后，压缩力辅助间隔件40沿近端方向16滑动而恢复其初始位置。
现在参考图4，示出了血液控制导管组件100。在一些实施例中，导管组件100包括间隔件促动器130，其具有经由管腔136互连的探头部132和导管楔形件134。导管楔形件134插入导管50的基部52中以将导管50紧固到导管适配器20的远端24。探头部132从导管楔形件134朝向导管适配器120的近端122向外延伸。在一些实施例中，探头部132在导管适配器120的流体通道26内大体轴向居中布置。间隔件促动器130的管腔136将探头部132和导管楔形件134互连且提供它们之间的流体连通。探头部132与导管楔形件134之间的距离一般被选择为允许间隔件40沿远端方向14滑动一定距离，该距离足以使探头部132前进通过膜48的狭缝42，从而提供导管50、管腔136、向后腔室46与流体通路26之间的流体连通。
在一些实例中，选择探头部132与导管楔形件134之间的距离，以便防止探头部132穿过狭缝42过度插入。例如，可选择探头部132与导管楔形件134之间的距离，以便当实现探头部132穿过狭缝42的期望最大贯穿量时，实现间隔件40的远端与导管适配器130的内壁表面128之间的接触。
在一些实施例中，间隔件40包括的外直径比内表面128的缩减直径154略大。间隔件40在缩减直径154处与内表面128形成流体紧密封。因此，间隔件40将流体通路26划分成近端流体腔室146与远端流体腔室148。在一些实例中，不希望流体泄漏到远端流体腔室148中。因此，导管楔形件134与导管50的基部52形成流体紧密封。此外，探头部132的外直径比前向插座44的内直径略大。因此，在前向插座44处提供探头部132与间隔件40之间的流体紧密封。
现在参考图5，显示出导管组件100的分解图。在一些实施例中，通过首先将导管50插入导管适配器120中，使得导管50的基部52定位在远端24中来组装导管组件100。通过将间隔件促动器130的导管楔形件134插入底座52中，导管50被紧固到导管适配器120上。导管楔形件134被构造为通过插入导管50且在导管楔形件134与远端24之间压缩基部52而将导管50紧固到导管适配器130。该压缩配合提供导管50与间隔件促动器130之间的流体紧密封，从而防止流体泄漏到远端流体腔室148中。该流体紧密封提供了导管50与间隔件促动器130的管腔136之间的流体连通。
在导管50和间隔件促动器103紧固之后，间隔件40在近端122处插入到导管适配器120中。间隔件40滑入导管适配器120中，使得间隔件促动器130的探头部132插入前向插座44中。在一些实施例中，间隔件40定位在流体通路26中，使得膜48抵接探头部132。
在间隔件40沿远端方向14进一步移动时，探头部132前进穿过膜48的狭缝42，从而提供间隔件促动器130的管腔136与间隔件40的后向插座46之间的流体连通，如图6所示。例如，诸如鲁尔适配器的外部装置12可以插入近端122以接触间隔件40，并且沿远端方向14推进间隔件40。在一些实施例中，探头部132包括倾斜外表面138，该倾斜外表面138接触膜48且与膜48的上活瓣和下活瓣形成流体紧密封。因此，防止流体在膜48与倾斜外表面138之间泄漏。
在一些实施例中，本发明的血液控制导管组件包括一个或多个涂覆有抗病原材料的表面。可提供抗病原材料，以防止病原体在导管组件的各部件上移生。另外，包括润滑剂的抗病原材料可以施加到导管组件的各部件上，以减小相接表面之间的摩擦且防止病原体在接口处的移生。
在一些实例中，在组装导管组件之前，抗病原材料首先施加到内表面28/128上。通过这样方式，抗病原材料在组装和使用期间从内表面28/128转移到其他各部件上。在其他实例中，在导管组件插入导管适配器中之前，抗病原材料施加到导管组件的各部件上。这样，在组装和使用期间，抗病原材料从各部件转移到导管适配器上。
在一些实施例中，内表面28/128涂覆有刚性的或半刚性的抗病原材料，使得流经流体通路26的流体与抗病原材料相接触。因此，防止细菌在涂层表面上的移生。抗病原材料的刚性的或半刚性的性质防止从表面轻易地去除涂层。因此，在抗病原材料的有效持续期内，表面保持涂层。在一些实例中，抗病原材料的刚性的或半刚性的性质允许表面有涂层，而不妨碍表面的关键尺寸，如序号为13/471,716的美国专利申请所教导的那样。
在其他实施例中，内表面28/128涂有粘性的或流体的抗病原材料，该抗病原材料包括润滑剂，诸如硅油。在一些实例中，润滑涂层设在间隔件40与内表面28/128之间的相接表面上。间隔件40可以包括当抵靠诸如内表面28/128的聚合物表面移动时显现出高摩擦性的材料。例如，间隔件40可以包括硅材料，当间隔件40在导管适配器120的流体腔室26内移动时，该硅材料显现出“粘性”特性。因此，在一些实施例中，有益的是，将润滑的抗病原材料放置在间隔件40和导管适配器120的相接表面之间，以利于间隔件40在导管适配器120内可滑动地运动。因此，本发明的抗病原涂层材料可以包括实现该益处的润滑剂。
现在参考图7，在一些实施例中，在组装导管组件10之前，将抗病原材料80施加到间隔件40的各表面上。例如，刚性的抗病原材料82可优选用在间隔件40的与流经导管组件10的流体直接接触的表面上。在一些实例中，刚性的抗病原材料82可以施加到后向插座46上，其中在使用导管组件100期间，后向插座46与流体直接接触。刚性的抗病原材料82通常更耐磨损，并且因此可以施加到易于磨损的表面上，例如与流体直接接触的表面上。刚性的抗病原材料82还可以包括施加到具有关键尺寸的表面上的薄层。例如，后向插座46的直径可以对方便流体通过间隔件40的正确流体动力学其关键作用。可替代地，后向插座46的直径可以对接收外部装置的一部分起关键作用。
间隔件40还可以包括润滑的抗病原材料84，抗病原材料84施加到间隔件40的各表面上，以减小间隔件40与导管组件的另一装置或部件的表面之间的摩擦。例如，在一些实施例中，润滑的抗病原材料84施加到间隔件40的外表面90上以减小间隔件40与导管适配器的内表面之间的摩擦。此外，润滑的抗病原材料84可以施加到前向插座44的内表面上，以减小间隔件40与间隔件促动器130的探头部132之间的摩擦。除了减小摩擦之外，润滑的抗病原材料84为间隔件40提供抗病原性质，以防止病原体的移生。
在一些实施例中，润滑的抗病原材料84的流体本质允许润滑的抗病原材料84从间隔件40转移到与间隔件40相接触的其他表面上。例如，在一些实施例中，由于间隔件促动器定位在前向插座44内，沉积在前向插座44中的抗病原材料84转移到间隔件促动器130。另外，当间隔件促动器前进穿过间隔件40的狭缝42，润滑的抗病原材料84可以转移到间隔件促动器的其他表面。此外，随着间隔件40在导管适配器的流体通道26内向远端和向近端滑动，在间隔件40的外表面90上的润滑的抗病原材料84可以转移到导管适配器的内表面上。在一些实例中，随着外部装置12沿远端方向14插入导管适配器中而推进间隔件40，润滑的抗病原材料84进一步转移到外部装置12的各表面上。抗病原材料84转移到外部装置12可以减小外部装置12与导管适配器之间的摩擦。抗病原材料84转移到外部装置12可以进一步防止病原体在外部装置12上以及主要在流体通路26内的移生。依照上述的方法，刚性的抗病原材料82和润滑的抗病原材料84可以进一步转移到导管组件10的间隔件促动器30上。
现在参考图7，在一些实施例中，在导管组件组装之前，刚性的抗病原材料82和润滑的抗病原材料84施加到间隔件促动器130的各表面上。例如，在一些实例中，刚性的抗病原材料82施加到间隔件促动器130的内表面上，从而与流经管腔136的流体相接触。此外，润滑的抗病原材料84施加到间隔件促动器130的探头部132上。当间隔件40在导管适配器内沿远端方向14滑动，润滑的抗病原材料84减小探头部132与前向插座44之间的摩擦。润滑的抗病原材料84进一步减小了探头部130与膜48之间的摩擦，以利于探头部130穿过膜48的狭缝42容易插入。依照上述方法，刚性的抗病原材料82和润滑的抗病原材料84还可以施加到导管组件10的间隔件促动器30上。
在一些实施例中，润滑的抗病原材料84的流体本质允许润滑的抗病原材料84从间隔件促动器130转移到与间隔件促动器130相接触的其他表面上。例如，在一些实施例中，随着间隔件促动器130在组装期间插入前向插座44，沉积或涂覆到间隔件促动器130的探头部132上的抗病原材料84转移到前向插座44上。另外，当间隔件促动器前进穿过间隔件40的狭缝42，润滑的抗病原材料84可以转移到间隔件40的其他表面上，诸如膜48和狭缝42。在一些实例中，润滑的抗病原材料84从探头部132转移到狭缝42，从而进一步为狭缝42提供流体紧密封。
在一些实例中，在组装导管组件之前，润滑的抗病原材料84和刚性的抗病原材料82施加到间隔件和间隔件促动器上。在其他实例中，过量的润滑抗病原材料84施加到间隔件和间隔件促动器上，目的在于在组装导管组件的各部件时将过量的抗病原材料转移到导管组件的各表面上。
一般地，本发明的抗病原材料可以施加到医疗装置或医疗装置的部件的任意内表面或外表面上，其中所述表面包括通过医疗装置的流体通路或者暴露于医疗装置的流体通路。所述表面还可以包括关键尺寸和非关键尺寸。因此，防止穿过医疗装置的流体内的病原体在医疗装置内移生。在一些实施例中，抗病原材料的厚度与抗病原材料在涂层表面上的有效持续期成比例。因此，可以通过增加施加到表面上的抗病原材料的厚度来延长涂层的有效持续期。还可以通过调整抗病原材料的物理属性来提高或降低抗病原剂能够从涂层材料中洗脱的速率，进而调整有效持续期。
在一些实施例中，选择刚性或半刚性的抗病原材料82，其配置成允许包含在材料82内的抗病原剂的长期洗脱。因此，期望为导管组件的大量的流体路径表面积提供抗病原材料。在其他实施例中，选择粘性的、流体抗病原材料84，其进一步包括润滑剂。例如，在一些实施例中，提供润滑的抗病原材料84，其进一步包括硅润滑剂，诸如MED-460(由NuSilTechnology,LLC制造)。包含润滑剂减小了导管组件的相接部件之间的摩擦。在一些实施例中，润滑的抗病原材料84进一步提供导管组件的各部件之间的流体紧密封。
在一些实施例中，润滑的抗病原材料84包括防止或控制润滑的抗病原材料在导管组件内过量迁移的调整流变学。例如，润滑的抗病原材料84可以进一步包括流变调节剂，以提高诸如硅石、滑石或粘土的材料的粘度。
对导管组件的相容表面涂覆或施加抗病原材料的过程可以通过将装置的期望部分或部件浸渍在其相应的涂层材料82和/或64中来实现。可替代地，抗病原材料可以被喷涂到期望的表面上。在一些实施例中，在将抗病原材料施加到其余表面上之前，对具有关键尺寸的表面加掩模或以其他方式保护。相容的表面还可以包括促进涂层材料与相容表面之间的机械结合的机械特征。
例如，相容表面可被设计成包括增强涂层材料的机械结合的物理特征，诸如纹理、槽、脊状件或增大相容表面的表面积的一些其他特征。在一些实施例中，通过包括空隙的机械互锁来便于机械接合，所述空隙通过毛细力或表面张力来保持抗病原材料。在其他实施例中，机械互锁包括施加到相容表面上以吸引抗病原材料的亲水或疏水的材料或涂层。
此外，在一些实施例中，抗病原材料通过例如表面交联的化学键合来与导管组件或医疗装置的相容表面化学结合。例如，在一些实施例中，装置的相容表面包括能够与抗病原材料的至少一种成分形成化学键合的聚合物材料。可用来实现表面交联的聚合物材料的非限制性示例包括聚碳酸酯、聚酯和聚氨酯。在一些实例中，抗病原材料施加到装置的相容表面上，然后固化以实现抗病原材料与装置表面之间的表面交联。
本发明可体现为其他具体的形式，而不脱离如本文概述的和在下面权利要求中所主张的结构、方法或其他重要特征。所描述的实施方案的所有方面应仅仅是说明性的，而非限制性的。因此，本发明的范围由随附的权利要求书限定，而不是通过前面的说明而限定。落入权利要求的含义和其等同范围内的所有改变包含在发明的范围内。
本发明的各个实施例可适于与包括其中设有间隔件的管腔的任何医疗装置或附件一起使用。例如，在一些实施例中，与静脉管道的一段耦接的母鲁尔适配器可包括依照本发明教导的间隔件和间隔件促动器。在其他实施例中，y型端口适配器的一个或多个端部可以包括依照本发明教导的间隔件和间隔件促动器。
Claims (20)
1.一种导管组件，其特征在于，所述导管组件包括：
导管适配器，所述导管适配器具有近端开口、远端和在所述近端开口与所述远端之间延伸的流体通路，所述导管适配器的远端容纳导管；
间隔件，所述间隔件可滑动地布置在所述流体通路内，所述间隔件将所述流体通路划分成近端流体腔室和远端流体腔室；
间隔件促动器，所述间隔件促动器固定定位在所述远端流体腔室内且具有探头表面，所述探头表面配置成当所述间隔件在所述流体通路内朝向所述导管适配器的远端前进时将所述间隔件偏置到打开位置。
2.如权利要求1所述的导管组件，其特征在于，所述间隔件促动器还包括包含楔形件的第一端、包含探头的第二端以及在所述第一端与所述第二端之间延伸的管腔，所述第一端插入所述导管的基部，以使所述导管的基部与所述导管适配器的远端耦接，所述探头定位在所述远端流体腔室内。
3.如权利要求1所述的导管组件，其特征在于，所述导管组件还包括抗病原材料，所述抗病原材料被施加到所述间隔件促动器上，并且位于所述间隔件促动器与所述间隔件之间的相接表面。
4.如权利要求3所述的导管组件，其特征在于，所述抗病原材料包括润滑剂。
5.如权利要求1所述的导管组件，其特征在于，所述导管适配器、间隔件和间隔件促动器中的至少一个还包括暴露于所述流体通路的表面。
6.如权利要求5所述的导管组件，其特征在于，所述导管组件还包括抗病原材料，所述抗病原材料施加在所述暴露于所述流体通路的表面上。
7.如权利要求6所述的导管组件，其特征在于，所述抗病原材料包括润滑剂。
8.如权利要求6所述的导管组件，其特征在于，所述暴露于所述流体通路的表面的一部分包括非关键尺寸。
9.如权利要求1所述的导管组件，其特征在于，所述导管组件还包括抗病原材料，所述抗病原材料施加到所述间隔件的外表面上，并且位于所述间隔件与所述导管适配器的内表面之间的相接表面。
10.如权利要求9所述的导管组件，其特征在于，所述抗病原材料包括润滑剂。
11.如权利要求10所述的导管组件，其特征在于，所述润滑剂是硅基润滑剂。
12.如权利要求3所述的导管组件，其特征在于，所述抗病原材料是刚性的或半刚性的。
13.如权利要求9所述的导管组件，其特征在于，所述抗病原材料是刚性的或半刚性的。
14.如权利要求3所述的导管组件，其特征在于，所述导管组件还包括指示所述抗病原材料的具体类型的标识色。
15.如权利要求3所述的导管组件，其特征在于，所述抗病原材料以期望厚度施加到所述间隔件促动器上，所述期望厚度与所述抗病原材料在所述相接表面上的有效持续期成比例。
16.如权利要求3所述的导管组件，其特征在于，所述抗病原材料与所述流体通路的一部分相连通。
17.如权利要求2所述的导管组件，其特征在于，所述导管组件还包括：
介于所述间隔件促动器与所述间隔件之间的第一抗病原材料；
施加到所述间隔件促动器的管腔上的第二抗病原材料；
施加到所述间隔件的包含非关键尺寸的表面上的第三抗病原材料；以及
介于所述间隔件与所述导管适配器的内表面之间的第四抗病原材料。
18.如权利要求17所述的导管组件，其特征在于，所述第一抗病原材料和第四抗病原材料包括润滑剂。
19.如权利要求17所述的导管组件，其特征在于，所述第二抗病原材料和第三抗病原材料是刚性的或半刚性的。
20.如权利要求17所述的导管组件，其特征在于，所述第二抗病原材料和第三抗病原材料通过机械接合和化学键合中的至少一种来施加。
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| CA2943416C (en) | 2014-03-25 | 2019-10-29 | Orthopaedic Innovation Centre Inc. | Antimicrobial articles produced by additive manufacturing |
| US10376686B2 (en) | 2014-04-23 | 2019-08-13 | Becton, Dickinson And Company | Antimicrobial caps for medical connectors |
| US9789279B2 (en) | 2014-04-23 | 2017-10-17 | Becton, Dickinson And Company | Antimicrobial obturator for use with vascular access devices |
| US10232088B2 (en) | 2014-07-08 | 2019-03-19 | Becton, Dickinson And Company | Antimicrobial coating forming kink resistant feature on a vascular access device |
| US10493244B2 (en) | 2015-10-28 | 2019-12-03 | Becton, Dickinson And Company | Extension tubing strain relief |
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2013
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109069791A (zh) * | 2016-03-14 | 2018-12-21 | 观察医学有限责任公司 | 导管系统中的生物膜预防件 |
| CN109069791B (zh) * | 2016-03-14 | 2021-03-26 | 观察医学有限责任公司 | 导管系统中的生物膜预防件 |
| US11213651B2 (en) | 2016-03-14 | 2022-01-04 | Observe Medical Aps | Biofilm prevention in catheter systems |
Also Published As
| Publication number | Publication date |
|---|---|
| AU2018202408B2 (en) | 2019-07-11 |
| EP3431130A1 (en) | 2019-01-23 |
| MX2015010181A (es) | 2015-11-25 |
| US9750928B2 (en) | 2017-09-05 |
| AU2018202408A1 (en) | 2018-04-26 |
| EP2956200B1 (en) | 2018-10-24 |
| JP2020028729A (ja) | 2020-02-27 |
| ES2707952T3 (es) | 2019-04-08 |
| BR112015019137A2 (pt) | 2017-07-18 |
| AU2014216479B2 (en) | 2018-02-22 |
| US11357962B2 (en) | 2022-06-14 |
| WO2014126866A1 (en) | 2014-08-21 |
| US20170368326A1 (en) | 2017-12-28 |
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| JP6618804B2 (ja) | 2019-12-11 |
| EP2956200A1 (en) | 2015-12-23 |
| BR112015019137B1 (pt) | 2021-11-16 |
| ES2794911T3 (es) | 2020-11-19 |
| CA2900361C (en) | 2020-05-05 |
| MX359644B (es) | 2018-10-04 |
| CA2900361A1 (en) | 2014-08-21 |
| US20140228775A1 (en) | 2014-08-14 |
| AU2014216479A1 (en) | 2015-08-13 |
| JP2016506855A (ja) | 2016-03-07 |
| US20220265986A1 (en) | 2022-08-25 |
| JP6942169B2 (ja) | 2021-09-29 |
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