CN204932537U - 用于血管接入装置的密闭装置 - Google Patents

用于血管接入装置的密闭装置 Download PDF

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CN204932537U
CN204932537U CN201520248136.4U CN201520248136U CN204932537U CN 204932537 U CN204932537 U CN 204932537U CN 201520248136 U CN201520248136 U CN 201520248136U CN 204932537 U CN204932537 U CN 204932537U
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blood vessel
obturator
access device
vessel access
antibacterial
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乔纳森·K·伯克豪斯
悉达·K·舍伍古尔
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    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
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    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
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    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M25/0043—Catheters; Hollow probes characterised by structural features
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    • A61M39/02—Access sites
    • A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
    • A61M2039/0285—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body with sterilisation means, e.g. antibacterial coatings, disinfecting pads, UV radiation LEDs or heating means in the port

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Abstract

本申请涉及一种用于血管接入装置的密闭装置，所述密闭装置包括：导管部，该导管部被配置成当血管接入装置的导管通过静脉放置于患者体内时，所述导管部穿过所述血管接入装置的内腔并插入所述血管接入装置的导管的近端；以及盖部，该盖部被配置成将所述密闭装置固定至所述血管接入装置；其中，所述导管部包括抗菌涂层，所述抗菌涂层被配置成将抗菌剂释放至所述血管接入装置内所容纳的流体中。

Description

用于血管接入装置的密闭装置
技术领域
本实用新型主要涉及用于外周静脉导管或其他血管接入装置的密闭装置。尤其是，本实用新型涉及一种密闭装置，该密闭装置被配置成在被插入血管接入装置时对所述血管接入装置提供抗菌保护。
背景技术
导管经常被用于各种注射治疗。例如，导管被用于向患者注射流体，比如生理盐水、各种药物以及全肠外营养液，还被用于从患者体内抽血，以及监测患者血管系统的各项参数。
与导管相关的血液感染是微生物通过血管导管和静脉注射通路装置传播至患者体内而导致的。这类感染是产生疾病和额外医疗花费的重要原因之一。更重要的是，这类感染经常导致患者死亡。
很多技术都被用来降低导管或其他静脉装置带来的感染风险。例如，导管被设计成在导管外表面或内表面上具有抗菌润滑剂或者抗菌涂层。类似地，抗菌润滑剂或涂层也被施加在导管组件的其他部件的表面、连接到导管组件的部件的表面、或者其他可能与患者血管直接接触的医疗设备的表面，或者可能与流入患者血管的流体直接接触的医疗设备的表面。此外，一些装置或部件是由浸有抗菌剂的材料组成的。
虽然这些技术是有益的，但是具有多方面的限制它们有效性的缺点。例如，将抗菌涂层或者润滑剂施加至许多装置或部件的复杂的内部或外部几何结构可能是很困难并且/或者很昂贵。而且，有些装置或部件所优选的制造材料并不适合施加抗菌涂层或者不能浸透抗菌剂。由于这些困难，提供抗菌保护的现有技术经常不被使用，或者即使被使用也未能充分地提供最大限度的抗菌保护。
实用新型内容
本实用新型涉及用于血管接入装置的密闭装置。按照本实用新型所配置的密闭装置可以包括抗菌特征，在所述血管接入装置未用于注射或者未以其他方式进入患者血管时，所述抗菌特征有助于对血管接入装置内所含流体实施灭菌或保持其无菌性。
这些抗菌特征包括施加至密闭装置众多表面上的抗菌涂层以及粘结或以其他方式固定在密闭装置上的抗菌部件。可以根据需要将抗菌涂层和/或部件的多种组合使用在密闭装置上，以将所需数量的抗菌剂提供至血管接入装置的特定封闭腔体内。
根据本实用新型的一个方面，提供一种用于血管接入装置的密闭装置，所述密闭装置包括：导管部，该导管部被配置成当血管接入装置的导管通过静脉放置于患者体内时，所述导管部穿过所述血管接入装置的内腔并插入所述血管接入装置的导管的近端；以及盖部，该盖部被配置成将所述密闭装置固定至所述血管接入装置；其中，所述导管部包括抗菌涂层，所述抗菌涂层被配置成将抗菌剂释放至所述血管接入装置内所容纳的流体中。
在一些实施例中，所述抗菌涂层包含可溶解的涂层。
在一些实施例中，所述抗菌涂层包括可洗脱出抗菌剂的基材基质。
在一些实施例中，所述基材基质被固化到所述导管部上。
在一些实施例中，所述抗菌涂层容纳在所述导管部的位于所述血管接入装置的导管内的部段上。
在一些实施例中，所述导管部的部段还延伸进入血管接入装置的内腔中。
在一些实施例中，所述密闭装置进一步包括：固定至所述密闭装置的抗菌部件，所述抗菌部件被配置成将抗菌剂释放至所述血管接入装置内所容纳的流体中。
在一些实施例中，所述抗菌部件包括抗菌涂层。
在一些实施例中，所述抗菌部件包括基材基质，所述基材基质用于洗脱出抗菌剂。
在一个实施例中，本实用新型被实施成一种用于血管接入装置的密闭装置。该密闭装置包括导管部，该导管部被配置成当血管接入装置的导管通过静脉放置于患者体内时，所述导管部穿过所述血管接入装置的内腔并插入所述血管接入装置的导管的近端，该密闭装置还包括盖部，该盖部被配置成将所述密闭装置固定至所述血管接入装置。所述导管部包括抗菌涂层，所述抗菌涂层被配置成向在所述血管接入装置中容纳的流体释放抗菌剂。
在另一个实施例中，本实用新型被实施成一种用于血管接入装置的密闭装置。该密闭装置包括导管部，该导管部被配置成当血管接入装置的导管通过静脉放置于患者体内时，所述导管部穿过所述血管接入装置的内腔并插入所述血管接入装置的导管的近端；该密闭装置还包括中间部分，该中间部分被配置成当所述导管部被插入所述导管中时，所述中间部分位于所述血管接入装置的内腔中；该密闭装置还包括盖部，该盖部被配置成将密闭装置固定至所述血管接入装置。所述密闭装置还进一步包括围绕所述中间部分布置的抗菌环，所述抗菌环被配置成向在所述血管接入装置的内腔中容纳的流体释放抗菌剂。
在另一个实施例中，本实用新型被实施成一种用于血管接入装置的密闭装置。该密闭装置包括导管部，该导管部被配置成当所述血管接入装置的导管通过静脉放置于患者体内时，所述导管部穿过所述血管接入装置的内腔并插入所述血管接入装置的导管的近端；所述密闭装置还包括基部，该基部被配置成插入所述内腔而密封所述内腔。所述密闭装置还进一步包括抗菌部件，该抗菌部件被配置成向在所述血管接入装置的内腔中容纳的流体释放抗菌剂。
根据本实用新型的另一个方面，提供一种用于血管接入装置的密闭装置，所述密闭装置包括：导管部，该导管部被配置成当所述血管接入装置的导管通过静脉放置于患者体内时，所述导管部穿过所述血管接入装置的内腔并插入所述血管接入装置的导管的近端；中间部分，该中间部分被配置成当所述导管部被插入所述导管内时，所述中间部分位于所述血管接入装置的内腔内；盖部，该盖部被配置成将密闭装置固定至所述血管接入装置；以及围绕所述中间部分设置的抗菌环，所述抗菌环被配置成将抗菌剂释放至所述血管接入装置内腔中所容纳的流体中。
在一些实施例中，所述抗菌环包括可洗脱出抗菌剂的基材基质。
在一些实施例中，所述基材基质在所述抗菌环上形成抗菌涂层。
在一些实施例中，所述导管部包括抗菌涂层，所述抗菌涂层被配置成将抗菌剂释放至所述血管接入装置中所容纳的流体中。
在一些实施例中，所述抗菌涂层可溶解。
在一些实施例中，所述抗菌涂层包括可洗脱出抗菌剂的基材基质。
在一些实施例中，所述密闭装置进一步包括：基部，该基部的直径与所述内腔的直径大致相同，所述基部被配置成当密闭装置固定至所述血管接入装置时密封所述内腔。
根据本实用新型的又一个方面，提供一种用于血管接入装置的密闭装置，所述密闭装置包括：导管部，该导管部被配置成当所述血管接入装置的导管通过静脉放置于患者体内时，所述导管部穿过所述血管接入装置的内腔并插入所述血管接入装置的导管的近端；基部，该基部被配置成插入所述内腔以密封所述内腔；抗菌部件，该抗菌部件被配置成将抗菌剂释放至所述血管接入装置内腔中所容纳的流体中。
在一些实施例中，所述抗菌部件包括围绕所述密闭装置的一部分固定的环。
在一些实施例中，所述导管部包括抗菌涂层，所述抗菌涂层被配置成将抗菌剂释放至所述血管接入装置中所容纳的流体中。
在一些实施例中，所述抗菌部件包括可洗脱出抗菌剂的基材基质。
本部分内容旨在简单介绍将在以下具体实施方式部分做进一步描述的一系列概念。本概述部分并非要确定所要求保护主题的关键特征或必要特征。
本实用新型的其他特征和优点将在下文的说明中进行描述，并且有些可从该说明中明显得出，或者可以通过实施本实用新型而得出。本实用新型的特征和优点可以通过权利要求书所特别指出的装置及其组合来认识和获得。本实用新型的上述以及其他特征将会通过下文的描述和权利要求书而变得更加清楚，或者可以通过如本文所述地实施本实用新型而获得。
附图说明
为了描述获得本申请的上文所述的以及其他的特征及优点的方式，将参照示出于附图中的本实用新型的具体实施例来更加具体地描述前文所简述的内容。可以理解，这些附图仅描绘了本实用新型的若干典型实施方式，因此不应认为是对本实用新型的范围的限定。以下将使用附图更加明确和详细地描述和解释本实用新型。
图1A-1C分别例示了根据本实用新型的一个或多个实施例的包括抗菌涂层的密闭装置。图1A例示了密闭装置在插入血管接入装置之前的前透视图。图1B例示了图1A所示的密闭装置在被插入血管接入装置之前的剖面正视图。图1C例示了图1A和1B所示的密闭装置在被插入血管接入装置之后的状态，此处的血管接入装置为外周静脉导管。
图2A-2D分别例示了根据本实用新型的一个或多个实施例的包括抗菌环的密闭装置。图2A例示了所述密闭装置在被插入血管接入装置之前的正视透视图。图2B例示了图2A所示的密闭装置未被插入血管接入装置时的剖面正视图。图2C例示了图2A和2B所示的密闭装置在被插入血管接入装置之后的状态，此处的血管接入装置为外周静脉导管。图2D例示了图2A-2C所示的密闭装置在被放置于开口导管内时的剖面透视正视图。
图3A和图3B为具有抗菌涂层的密闭装置和血管接入装置的剖面正视图。图3A例示了所述密闭装置未被插入血管接入装置时的状态。图3B例示了所述密闭装置被插入血管接入装置之后的状态以及容纳在抗菌涂层中的抗菌剂是如何释放到血管接入装置内腔中所容纳的流体中的。
图4A和4B提供了具有抗菌环的密闭装置和血管接入装置的剖面正视图。图4A例示了所述密闭装置未被插入血管接入装置时的状态。图4B例示了所述密闭装置被插入血管接入装置之后的状态以及容纳在抗菌环中的抗菌剂是如何释放到血管接入装置内腔中所容纳的流体中的。
具体实施方式
本实用新型涉及用于血管接入装置的密闭装置。按照本实用新型进行配置的密闭装置包括抗菌特征。所述抗菌特征在所述血管接入装置未用于注射或者以其他方式介入患者血管时，帮助对血管接入装置内所容纳的流体实施杀菌或保持其无菌性。
这些抗菌特征包括施加至密闭装置的多个表面的抗菌涂层，以及粘结或以其他方式固定至密闭装置的抗菌部件。可以根据需要将抗菌涂层和/或部件的多种组合使用在密闭装置上，以向血管接入装置的特定封闭腔体内提供所需数量的抗菌剂。
在某个具体实施例中，本实用新型被实施成一种用于血管接入装置的密闭装置。该密闭装置包括导管部，该导管部被配置成当血管接入装置的导管通过静脉放置于患者体内时，所述导管部穿过所述血管接入装置的内腔并插入所述血管接入装置的导管的近端，该密闭装置还包括盖部，该盖部被配置成将所述密闭装置固定在所述血管接入装置上。所述导管部包括抗菌涂层，所述抗菌涂层被配置成向所述血管接入装置中容纳的流体释放抗菌剂。
在另一个具体的实施方式中，本实用新型被实施成一种用于血管接入装置的密闭装置。该密闭装置包括导管部，该导管部被配置成当血管接入装置的导管通过静脉放置于患者体内时，所述导管部穿过所述血管接入装置的内腔并插入所述血管接入装置的导管的近端；该密闭装置还包括中间部分，该中间部分被配置成当所述导管部被插入所述导管中时，所述中间部分被放置在所述血管接入装置的内腔中；该密闭装置还包括盖部，该盖部被配置成将密闭装置固定在所述血管接入装置。所述密闭装置还进一步包括围绕所述中间部分设置的抗菌环。所述抗菌环被配置成向所述血管接入装置内腔中所容纳的流体释放抗菌剂。
在另一个具体的实施方式中，本实用新型被实施成一种用于血管接入装置的密闭装置。该密闭装置包括导管部，该导管部被配置成当所述血管接入装置的导管通过静脉放置于患者体内时，所述导管部穿过所述血管接入装置的内腔并插入所述血管接入装置的导管近端。该密闭装置还包括基部，该基部被配置成被插入所述内腔以密封所述内腔。所述密闭装置还进一步包括抗菌部件，该抗菌部件被配置成向所述血管接入装置内腔中所容纳的流体释放抗菌剂。
当血管接入装置的导管被放置入静脉中但并未用于注射、给药或其他类型的血管介入时，用于血管接入装置的密闭装置经常被用作密封血管接入装置的导管内腔的手段。例如，当外周静脉导管将在大段时间内(比如24小时)不会被用来介入患者血管时，可以将密闭装置插入所述外周静脉导管。
图1A-1C示出了根据本实用新型所配置的密闭装置的一个具体实施例。图1A例示了被配置为插入外周静脉导管或其他血管接入装置的密闭装置100的透视图。图1B例示了密闭装置100的剖视图。图1C例示了在插入外周静脉导管150内时的密闭装置100的剖视图。
密闭装置100包括导管部101、中间部分102、基部103和盖部104。导管部101的尺寸被设定为可以插入外周静脉导管的导管。在许多情况下，导管部101的外径被配置成与其中使用有密闭装置100的外周静脉导管的导管的内径大致相同，从而使得导管部形成阻止流体流过导管的密封。因此，导管部可以被定义成密闭装置的被配置成插入血管接入装置的导管内的部分。
导管部101可以被配置成具有各种长度。例如，导管部101的长度可以被配置成使得导管部101的远端位于或接近所述血管接入装置的导管的远端。或者，导管部101的长度可以被配置成使得导管部101的远端从所述导管向远端伸出。类似的，导管部110的长度可以配置成使得导管部的远端邻近所述血管接入装置导管的远端。简而言之，导管部101的具体长度对本实用新型并非必要，导管部101可以采用任意长度，只要导管部101在密闭装置100插入所述血管接入装置内时至少部分地延伸进入所述导管即可。
中间部分102包括密闭装置的位于导管部101和基部103之间的一段。在图1A-1C中，所示出的中间部分102具有比导管部101更大的直径。不过，中间部分102还可以被配置成具有和导管部101的直径相同或更小的直径。中间部分102位于导管部101和基部103之间，从而其保留在密闭装置100所被放置的血管接入装置的内腔中。相应的，中间部分102更具体地是指密闭装置的一段而不是密闭装置的独立或可区别开的部分。因此，即使图中将中间部分102示出为密闭装置的具有不同于其他部分的直径的部段，但这并不是必需的。
基部103包括密闭装置的一部分，该部分直径与其中使用该密闭装置的血管接入装置的内径的直径基本相同。因此，基部103的目的之一是密封血管接入装置的内腔。虽然如图所示的密闭装置包括配置成密封血管接入装置内腔的基部，但是根据本实用新型的密闭装置并非必须包括以这种方式配置的基部。例如，密闭装置可以包括直径小于内腔直径的基部，从而使得基部不能密封内腔。
盖部104包括密闭装置100的近端部分，该部分被配置成将密闭装置固定至所述血管接入装置。在如图所示的一些具体实施方式中，盖部104可以被配置成延伸超过所述血管接入装置的近端。在某些实施例中，盖部104的内表面可以包括用以将盖部104固定在所述血管接入装置上的螺纹。或者，盖部104的内表面可以被配置成与所述血管接入装置的外表面形成摩擦配合。在另一些实施例中，盖部104可以被设计成没有任何部分延伸超过所述血管接入装置的外部。大体上，盖部104可以被定义成密闭装置的用户可以抓住以将所述密闭装置插入所述血管接入装置或从中取出的部分。在许多情况下，盖部104还可以形成为在所述血管接入装置的近端开口上的盖子，但是这并不是本实用新型所必需的。
虽然此处将密闭装置描述为包括可区别的导管部分、中间部分、基部和盖部，但是此描述的目的在于帮助理解本实用新型，而不应当被理解成是对权利要求的限制。尤其是，根据本实用新型的密闭装置可以被配置成仅具有可区别的盖部和导管部分，其中盖部是供用户抓握的部分而导管部分从盖部向远端延伸。
根据本实用新型的一个或多个具体实施方式，密闭装置100还可以在一个或多个部分上包括抗菌涂层。所述抗菌涂层的位置可以被选择为使得在所述血管接入装置使用完后，抗菌涂层可以和血管接入装置中残留的流体接触。当残留流体接触抗菌涂层时，涂层中包含的一种或多种抗菌剂会被分散(例如洗脱或溶解)到残留流体中，从而对流体灭菌或保持流体无菌。这样，所述微生物在血管接入装置中传播的风险就会降低。
如图1A-1C所示，抗菌涂层110(图中未显示)可以被施加到导管部101上。抗菌涂层110可以沿着导管部101的任意长度延伸。如图所示，抗菌涂层从导管部101的远端延伸到中间部分102。在一些实施例中，抗菌涂层还可沿着中间部分102和/或基部103延伸。在另一些实施例中，抗菌涂层110可仅仅被施加到中间部分102和/或基部103上。
如1C所示，密闭装置100可以插入到外周静脉导管150(或者其他血管接入装置)内。外周静脉导管150包括具有内腔153的导管座152以及从导管座152向远端延伸的导管151。如图所示，密闭装置100可以插入外周静脉导管150从而使得导管部101延伸进入导管151。盖部104可以被配置成延伸到导管座的近端或近端开口之上。
如图1C所示的实施例中，基部103被配置成具有和内腔153大体相同的直径。因此，当密闭装置100完全插入外周静脉导管150时，基部103在内腔153内形成密封。同时，当密闭装置100完全插入时，导管部101的近端位于内腔153内。为此，导管部101的包括抗菌涂层110的部分容纳在内腔153中。这样，内腔153内的任何残留流体将与抗菌涂层110接触，从而使得抗菌涂层中的抗菌剂分散到流体中。类似地，导管151中残留的任何流体将会与导管部101的位于导管151内的部段上的抗菌涂层110接触。因此，抗菌剂能够从密闭装置100分散到导管151和内腔153中。
图2A-2C例示了根据本实用新型配置成的密闭装置的另一个实施例。图2A例示了被配置成插入外周静脉导管或其他血管接入装置的密闭装置200的透视图，图2B例示了密闭装置200的剖视图，而图2C例示了插入外周静脉导管250内的密闭装置200的剖视图。
密闭装置200和密闭装置100类似，包括导管部201、中间部分202、基部203和盖部204。在某些实施例中，密闭装置200还可以包括位于导管部201上的如上所述的抗菌涂层110。然而，在描述图2A-2C时，将假定密闭装置200不包括抗菌涂层110。
根据本实用新型一个或多个具体实施方式，密闭装置200还包括抗菌环210。抗菌环210可以包含具有一种或多种抗菌剂的材料。所述抗菌剂可以包含在形成所述环的材料之中或材料表面(例如涂层)，下文将对此做进一步详细描述。所述抗菌环210的位置将被选择成使得抗菌环将与在使用后留存在血管接入装置内的残留流体相互接触。当这些残留流体与抗菌环接触时，环中的一种或多种抗菌剂将分散(例如洗脱或溶解)到残留流体中，从而对流体进行灭菌或者保持流体无菌。这样，所述微生物在血管接入装置中传播的风险就会降低。
如图2A-2C所示，抗菌环210围绕中间部分202设置。因此，当密闭装置如图2C所示插入外周静脉导管250时，抗菌环210将位于内腔253中。因为抗菌环210位与内腔253中，容纳于内腔253中的任何流体均可以和抗菌环210相互接触，从而导致包含在抗菌环210内部或表面的抗菌剂分散到流体中。
如上所述，在一些实施例中，抗菌环210可用于同时还包括位于其导管部上的抗菌涂层的密闭装置。同时使用两者可确保有足量的抗菌剂分散至导管和导管座的内腔中，因为抗菌环210可提供为有效处理更大体积的内腔所需的更大量的抗菌剂。
除了环状，也可以采用其他形状的抗菌部件。例如，多个不同形状的抗菌部件可以黏贴到密闭装置的各个位置从而为血管接入装置提供抗菌效果。因此，根据本实用新型的密闭装置可以包括附接到密闭装置或者以其他方式固定到密闭装置上的一个或多个抗菌部件。
根据本实用新型具体实施例，多种类型的抗菌涂层可应用到密闭装置上。在某些实施例中，包含一种或多种抗菌剂的醇基制剂可以通过浸润或喷涂的方式施加到所述密闭装置的表面上(比如导管部101)。在施加后，酒精可以从表面散去，留下包含抗菌剂的剩余物，从而形成抗菌涂层。在这些实施例中，如此形成的抗菌涂层将溶解到所述血管接入装置内的流体中。在密闭装置将在相对较短的持续时间中使用的情况下，优选使用可溶解的抗菌涂层，因为涂层的快速溶解可导致抗菌剂快速释放到流体中。可用于将制剂施加在密闭装置上的合适的制剂和方法的例子被公开于美国专利申请第13/438,559号中，其名称为《对医疗设备采用新的抗菌涂层材料的系统和方法》(SystemsandMethodsforApplyingaNovelAntimicrobialCoatingMaterialtoaMedicalDevice)，该专利通过引用并入本文。
在另一些实施例中，抗菌涂层可以由包括一种或多种抗菌剂的基质形成。例如，所述基质可以是聚合物或其他适合的材料，该材料被以固化(例如通过紫外线固化)或以其他方式结合到密闭装置的表面上。在这样的涂层中，所述抗菌剂将以受控制的方式从基质涂层被洗脱。可以被用于在密闭装置上形成抗菌涂层的合适的基质和施加所述基质的方法被描述在以下文献中：名称为《血管接入装置抗菌材料和解决方案》(VascularAccessDeviceAntimicrobialMaterialsandSolutions)的美国专利第8,512,294号；名称为《抗菌组合物》(AntimicrobialCompositions)的美国专利申请第12/397,796号；名称为《抗菌涂层组合物》(AntimicrobialCoatingCompositions)的专利申请第12/476,977号；名称为《对医疗设备采用新的抗菌涂层材料的系统和方法》(SystemsandMethodsforApplyinganAntimicrobialCoatingtoaMedicalDevice)的专利申请第12/490,235号；以及名称为《经皮肤侵入设备的抗菌涂层》(AntimicrobialCoatingforDermallyInvasiveDevices)的专利申请第12/831,880号。以上各专利均通过引用并入本文。
在某些实施例中，抗菌部件(例如，环)可以由任意合适的材料组成，并且可以包括由醇基制剂形成的抗菌涂层，或者如前文所述地具有基材基质(basematerialmatrix)以及抗菌剂。在另一些实施例中，所述抗菌部件的组成材料可以包括基材基质和抗菌剂。换句话说，抗菌部件可以完全由基材基质组成，或者可以仅仅具有包含基材基质或醇基制剂的涂层。不论哪种情况，抗菌部件可以与密闭装置粘结与机械连接。
在本实用新型的具体实施方式中，密闭装置可以被配置成具有上述三种主要抗菌保护中的一种或多种。换句话说，密闭装置可以包括使用醇基制剂形成的抗菌涂层、由基材基质组成的抗菌涂层以及抗菌部件(无论是完全由基材基质组成，仅仅具有基材基质涂层，还是具有醇基制剂涂层)。当密闭装置被用在血管接入装置中时，这些抗菌保护类型的不同组合可以被用在所述密闭装置上以提供所需要的抗菌特性。
在许多密闭装置的设计中，密闭装置的导管部和基部在血管接入装置的相对两端形成密封，从而在血管接入装置中有效地形成密闭的流体体积。根据通常可能存在血管接入装置中的流体体积，密闭装置可以被配置成具有适当的抗菌涂层和/或部件，以确保所述密闭的流体体积可被充分处理。
为了提供适量的抗菌剂，必须考虑的多个因素包括：抗菌涂层在密闭装置上的总面积或总量(例如，重量)；涂层或材料中抗菌剂的浓度；涂层或材料洗脱或分散所述抗菌剂的速率；以及抗菌剂的类型。例如，为了使导管座中的0.16cc密闭流体体积在24小时内保持用于绿脓杆菌的20ppm的标准抑菌浓度，需要从密闭装置中释放3.2μg的双氯苯双胍己烷。此外，为了获得用于绿脓杆菌的500ppm的标准杀菌浓度，需要从密闭装置中释放80μg的双氯苯双胍己烷。因此，在一个实施例中，如果密闭装置包括用醇基制剂形成的抗菌涂层(也就是，药剂从其中溶解的涂层)并且所述密闭装置想要针对绿脓杆菌提供防护，抗菌涂层的最小目标重量范围可能是3.5μg到81μg(取决于是需要抑菌浓度还是杀菌浓度)。另一方面，在一个实施例中，如果密闭装置包括抗菌涂层或包括含有抗菌剂的基材基质的部件，并且所述密闭装置需要提供24小时的抗菌保护，抗菌涂层或部件的合适表面积为小到2.5mm2。
上述实施例显示，可溶解的抗菌涂层的具体重量或者可洗脱的抗菌涂层或部件的表面积可以根据目标微生物、所需的抗菌效果(例如，抑菌或杀菌浓度)、抗菌剂保持有效的目标时间、涂层或部件的释放动力学(例如，溶解或洗脱速率)以及所使用的抗菌剂的类型(例如，葡萄糖酸氯己定和双氯苯双胍己烷)来做出选择。
在装置使用间隙采用密闭装置在血管接入装置内释放抗菌剂的一个好处在于，所述密闭装置可以调整为包括抗菌涂层或部件而不需要调整密闭装置的使用方式。密闭装置因此可以简单地在需要的精确时间点向装置的精确位置处释放抗菌剂。其另一个好处在于，所提供的密闭装置可以具有被配置成向装置的内部腔体分配精确数量的抗菌剂的抗菌涂层和/或部件。如上文所述，涂层和/或部件可以基于多种因素进行定制，从而针对给定的体积和所需的目的提供必要数量的抗菌剂。
图3A和3B例示了密闭装置上的抗菌涂层310如何向在血管接入装置中所容纳的流体散布抗菌剂。在这些图中，抗菌涂层用在所述密闭装置导管部上所显示的白点来表示。图3B例示了当所述密闭装置放入所述血管接入装置时，抗菌剂被散布到流体中，该流体由散布在整个装置内腔中的黑点来表示。在这个实施例中，假设内腔是装满流体的。然而，即使流体并没有充满内腔，所述抗菌剂依然能够被散布到内腔中的流体中。
图4A和4B例示了密闭装置上的抗菌环410如何将抗菌剂分散至血管接入装置中所容纳的流体内。和图3B一样，图4B例示了包含在抗菌部件之内或之上的抗菌剂(以白点代表)被散布到容纳在装置内腔中的流体(以黑点代表)中。
根据本实用新型的精神或基本特征，本实用新型可以以其他特定的形式来体现。在任何情况下，以上所描述的实施方式仅仅是说明性的而非限制性的。因此，本申请的保护范围由权利要求来限定，而非通过前述的描述来限定。所有落于权利要求的等同方式内的含义和范围的改变都包含在本申请的范围内。

Claims (20)

1.一种用于血管接入装置的密闭装置，其特征在于，所述密闭装置包括：
导管部，该导管部被配置成当血管接入装置的导管放置于患者静脉内时，所述导管部穿过所述血管接入装置的内腔并插入所述血管接入装置的导管的近端；以及
盖部，该盖部被配置成将所述密闭装置固定至所述血管接入装置；
其中，所述导管部包括抗菌涂层，所述抗菌涂层被配置成将抗菌剂释放至所述血管接入装置内所容纳的流体中。
2.根据权利要求1所述的密闭装置，其特征在于，所述抗菌涂层包含可溶解的涂层。
3.根据权利要求1所述的密闭装置，其特征在于，所述抗菌涂层包括可洗脱出抗菌剂的基材基质。
4.根据权利要求3所述的密闭装置，其特征在于，所述基材基质被固化到所述导管部上。
5.根据权利要求1所述的密闭装置，其特征在于，所述抗菌涂层容纳在所述导管部的位于所述血管接入装置的导管内的部段上。
6.根据权利要求5所述的密闭装置，其特征在于，所述导管部的部段还延伸进入血管接入装置的内腔中。
7.根据权利要求1所述的密闭装置，其特征在于，所述密闭装置进一步包括：
固定至所述密闭装置的抗菌部件，所述抗菌部件被配置成将抗菌剂释放至所述血管接入装置内所容纳的流体中。
8.根据权利要求7所述的密闭装置，其特征在于，所述抗菌部件包括抗菌涂层。
9.根据权利要求7所述的密闭装置，其特征在于，所述抗菌部件包括基材基质，所述基材基质用于洗脱出抗菌剂。
10.一种用于血管接入装置的密闭装置，其特征在于，所述密闭装置包括：
导管部，该导管部被配置成当血管接入装置的导管放置于患者静脉内时，所述导管部穿过所述血管接入装置的内腔并插入所述血管接入装置的导管的近端；
中间部分，该中间部分被配置成当所述导管部被插入所述导管内时，所述中间部分位于所述血管接入装置的内腔内；
盖部，该盖部被配置成将密闭装置固定至所述血管接入装置；以及
围绕所述中间部分设置的抗菌环，所述抗菌环被配置成将抗菌剂释放至所述血管接入装置内腔中所容纳的流体中。
11.根据权利要求10所述的密闭装置，其特征在于，所述抗菌环包括可洗脱出抗菌剂的基材基质。
12.根据权利要求11所述的密闭装置，其特征在于，所述基材基质在所述抗菌环上形成抗菌涂层。
13.根据权利要求10所述的密闭装置，其特征在于，所述导管部包括抗菌涂层，所述抗菌涂层被配置成将抗菌剂释放至所述血管接入装置中所容纳的流体中。
14.根据权利要求13所述的密闭装置，其特征在于，所述抗菌涂层可溶解。
15.根据权利要求13所述的密闭装置，其特征在于，所述抗菌涂层包括可洗脱出抗菌剂的基材基质。
16.根据权利要求10所述的密闭装置，其特征在于，所述密闭装置进一步包括：
基部，该基部的直径与所述内腔的直径大致相同，所述基部被配置成当密闭装置固定至所述血管接入装置时密封所述内腔。
17.一种用于血管接入装置的密闭装置，其特征在于，所述密闭装置包括：
导管部，该导管部被配置成当血管接入装置的导管放置于患者静脉内时，所述导管部穿过所述血管接入装置的内腔并插入所述血管接入装置的导管的近端；
基部，该基部被配置成插入所述内腔以密封所述内腔；以及
抗菌部件，该抗菌部件被配置成将抗菌剂释放至所述血管接入装置内腔中所容纳的流体中。
18.根据权利要求17所述的密闭装置，其特征在于，所述抗菌部件包括围绕所述密闭装置的一部分固定的环。
19.根据权利要求17所述的密闭装置，其特征在于，所述导管部包括抗菌涂层，所述抗菌涂层被配置成将抗菌剂释放至所述血管接入装置中所容纳的流体中。
20.根据权利要求17所述的密闭装置，其特征在于，所述抗菌部件包括可洗脱出抗菌剂的基材基质。
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CN106075700A (zh) * 2016-08-30 2016-11-09 李大跃 封堵式静脉留置导管

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