CN204723566U - 导管管体 - Google Patents
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- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
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- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/08—Tubes; Storage means specially adapted therefor
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
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Abstract
本实用新型涉及一种导管管体,所述导管管体包括:具有周长的外表面;和抗菌涂层,所述抗菌涂层被施加到所述外表面,从而形成不覆盖所述外表面的整个周长的图案。当将导管置于患者脉管系统中时,抗菌涂层将微生物在导管外表面定植的风险降到最低。
Description
技术领域
本实用新型主要涉及在导管管体外表面上具有抗菌涂层的导管以及制造该导管的方法。
背景技术
外周穿刺中心导管和其他中心静脉导管与医院内感染率增加相关。通常,导管引发的医院内感染是由沿所述导管管体外表面形成的生物膜造成的。为了解决这个问题,许多中心静脉导管在制造时在所述导管管体外表面使用抗菌涂层。当将所述导管管体置于患者脉管系统中时,这种涂层将微生物在表面定植的可能性降到最低。
通常,与中心静脉导管相比,外周静脉导管的驻留时间较短,本质上减少了生物膜在外周静脉导管的外表面上形成的风险。尽管如此,仍然有由于生物膜在外周静脉导管的外表面上形成的医院内感染的风险。
尽管目前用于将抗菌涂层施用于导管管体外表面的技术对中心静脉导管是有效的,但是这些技术对于外周静脉导管经常是不够的。例如,外周静脉导管经常被设置成在插管过程中允许可见回血。然而,通常用于中心静脉导管的所述涂层具有较差的透明度,因此影响了回流的能见度。此外,在生产外周静脉导管过程中,经常在扩口或型锻过程中拉抻导管管体。当拉抻用当前抗菌涂层处理过的导管管体时,所述涂层经常撕裂导致所述导管无法使用。由此,目前的用于将抗菌涂层施用于导管管体的技术已经被证实不足以用于外周静脉导管。
实用新型内容
本实用新型涉及在导管管体外表面包含抗菌涂层的导管以及制造具有涂层的导管的方法。当将导管管体置于患者脉管系统中时,抗菌涂层将微生物在导管管体外表面定植的风险降到最低。
根据本实用新型的一个方面,提供一种导管管体,其中所述导管管体包括:具有周长的外表面;和抗菌涂层,所述抗菌涂层被施加到所述外表面,从而形成不覆盖所述外表面的整个周长的图案。
在一些实施方式中,可以使用预处理工艺制造导管,所述预处理工艺先将抗菌涂层施加到导管管体,然后在涂层上施加润滑剂。在这种情况下,润滑剂可以起到将涂层保持在外表面上的作用,并且还能限制抗菌剂从涂层扩散。
在一些实施方式中,导管可以包含不影响回流能见度的抗菌涂层。由于抗菌涂层的透明度可能最低,因此可以将涂层以条带图案或其他使一部分外表面不被涂覆或涂覆最少的图案施加到外表面。通过导管管体上没有涂覆或涂覆最少的部分保持回流的可见度。
在一个示例性的实施方式中,本实用新型作为将抗菌涂层施用于导管管体的方法实施。含有溶剂和抗菌剂的溶液可以施用于导管管体的表面。随后允许所述溶剂蒸发而将所述抗菌剂留在所述导管管体的表面上。随后将润滑剂施用于所述涂层。一旦所述导管管体的表面接触流体,所述润滑剂能够限制所述抗菌剂从所述涂层扩散的速率。
在一些实施方式中,所述溶剂具有与在第一温度下的大气压力至少相当的蒸汽压,其中所述第一温度是所述抗菌剂的最高安全温度。
在一些实施方式中,所述溶剂包含乙醇且所述抗菌剂包含葡萄糖酸氯己定。
在一些实施方式中,所述溶剂使得导管管体扩张以允许所述抗菌剂渗透进入所述导管管体中。
在另一个示例性实施方式中,本实用新型作为将抗菌涂层以图案的方式施用于导管管体的方法实施。抗菌涂层施用于导管管体的外表面。随后使导管管体经过模具以从所述外表面除去抗菌涂层的一部分,从而在导管管体通过模具后其外表面上保留抗菌涂层的图案。
在一些实施方式中,所述图案包含一个或多个抗菌涂层的条带。
在一些实施方式中,所述导管管体的外表面包含一个或多个通道,并且所述图案包含在所述一个或多个通道中的抗菌涂层。
在一些实施方式中,所述图案包含不包括所述抗菌涂层的外表面的一个或多个部分,或包含包括微量的抗菌涂层的外表面的一个或多个部分,以便透过所述一个或多个部分保持导管管体管腔中的内容物的能见度。
在一些实施方式中,所述图案遵循导管管体中含有的不透射线材料。
在一些实施方式中,所述模具在其内表面包括一个或多个通道。所述一个或多个通道形成所述图案。
在一些实施方式中,所述导管管体包含具有尖端的导管管体的区段,并且没有将所述抗菌涂层施用于所述尖端。
在一些实施方式中,在将所述抗菌涂层施用于所述导管管体的外表面之前,将轴芯插入到所述导管管体的一端以防止抗菌涂层进入所述末端。在一些实施方式中,该末端包含与所述导管管体上形成的尖端相对的末端。
在另一个示例性实施方式中,本实用新型作为包含具有周长的外表面的导管管体实施;并且将抗菌涂层以图案施用于外表面,其中所述图案没有覆盖外表面的整个周长。
在一些实施方式中,所述图案包含多个条带,其通过在外表面的整个周长施加抗菌涂层之后使导管管体经过模具而在外表面而形成。
在一些实施方式中,在外表面中的多个通道中形成所述多个条带。
在一些实施方式中,所述导管管体进一步包含不透射线材料制成的条带,所述不透射线材料制成的条带沿所述导管管体的长度的方向延伸,其中所述图案的多个条带与所述不透射线材料制成的条带基本平行。
在一些实施方式中,所述导管管体包含尖端,所述抗菌涂层没有延伸到所述尖端。
本概述旨在以简化形式引入概念的选择。该概念的选择会在以下的发明详述中进一步描述。本概述并非旨在确定要求保护的主题的关键特性或重要特性。
本发明的附加特性和益处将在以下的描述中阐明,且一部分在描述中是显而易见的,或通过本发明的实践习得。本发明的特性和益处可以以通过仪器的方式和在所附权利要求中特别指出的组合的方式实现和获得。本发明的这些和其他特性在以下描述和所附的权利要求中将会更加全面透彻,或通过实践如以下的本发明而获得本发明的这些和其他特性。
附图说明
为了描述能够获得本发明前述和其他益处和特性的方式,通过引用其在所附的附图中展示的具体的实施方式来更加特定的描述以上简要描述过的本发明。应理解这些附图仅仅显示了本发明的通常的实施方式,因此并非旨在限定其范围,本发明将详细描述并通过使用附图的附加特征和细节说明,其中:
图1A-1C显示了在制造的不同阶段中导管管体100的一部分。图1A展示了在施用抗菌涂层之前的导管管体100。图1B展示了在施用抗菌涂层101后的导管管体100。图1C展示了将润滑剂102施用至抗菌涂层101后的导管管体100。
图2A-2D展示了根据本发明一个或多个实施方式向导管管体100施用抗菌涂层101和润滑剂102的过程。图2A展示了将导管管体100浸于在溶液200中,其中溶液200包括蒸发性溶剂和抗菌剂。图2B展示了从溶液200中移出的导管管体100,其中蒸发性溶剂蒸发,抗菌剂留在导管管体100的外表面。图2C展示了在蒸发性溶剂蒸发后留在导管管体100上的抗菌涂层101。图2D展示了施用至导管管体100的抗菌涂层101上的润滑剂102。
图3A-3C展示了包括抗菌涂层301的导管管体300,其中抗菌涂层301以与包含在导管管体中的不透射线材料305大体对齐排列的图案施用至导管管体。图3A展示了带有不透射线材料305的条带的导管管体300的透视图,其中不透射线材料305在导管管体中沿长度方向排列。图3B展示了导管管体300的剖视图。图3C展示了当将抗菌涂层301施用至导管管体外表面的不透射线材料305条带上时的导管管体300。
图4A-4C展示了包括不透射线材料405和用于包含抗菌涂层301的通道406的导管管体400。图4A展示了带有不透射线材料405的条带的导管管体400的透视图,其中不透射线材料405的条带在导管管体中沿长度方向排列。图4B展示了导管管体400的剖视图,其中导管管体400显示了通道406如何与不透射线材料405的条带大体对齐排列。图4C展示了将抗菌涂层301施用至通道406中的导管管体400。
图5A-5C展示了如何使用模具以在导管管体外表面形成抗菌涂层301的图案。图5A展示了具有在模具内表面上形成6个通道501用于形成六条条带图案的示例性模具580的俯视图。图5B展示了由于通过模具580而留下抗菌涂层301的六条条带的导管管体300的剖视图。图5C展示了在导管管体浸到含有抗菌涂层301的溶液中后如何使导管管体300通过模具580。
图6A和6B展示了如何将抗菌涂层向导管管体的一部分施用。图6A展示了导管管体600的示例,其中将抗菌涂层301施用至导管管体的主体而非尖端。图6B展示了使用模具680施用涂层图案的同时如何将抗菌涂层301施用至导管管体600而不将所述涂层施用至尖端。
具体实施方式
本发明涉及在导管管体外表面包含抗菌涂层的导管以及制造具有这种涂层的导管的方法。当将导管管体置于患者脉管系统中时,抗菌涂层将微生物在导管管体外表面定植的风险降到最低。
在一些实施方式中,可以使用预处理工艺制造导管,所述预处理工艺先将抗菌涂层施加到导管管体,然后在涂层上施加润滑剂。在这种情况下,润滑剂可以起到将涂层保持在外表面上的作用,并且还能限制抗菌剂从涂层扩散。
在一些实施方式中,导管可以包含不影响回流能见度的抗菌涂层。由于抗菌涂层的透明度可能最低,因此可以将涂层以条带图案或其他使一部分外表面不被涂覆或涂覆最少的图案施加到外表面。通过导管管体上没有涂覆或涂覆最少的部分保持回流的可见度。
在一个示例性的实施方式中,本实用新型作为将抗菌涂层施用于导管管体的方法实施。含有溶剂和抗菌剂的溶液可以施用于导管管体的表面。随后允许所述溶剂蒸发而将所述抗菌剂留在所述导管管体的表面上。随后将润滑剂施用于所述涂层上。一旦所述导管管体的表面接触流体,所述润滑剂能够限制所述抗菌剂从所述涂层扩散的速率。
在一些实施方式中,所述溶剂具有与在第一温度下的大气压力至少相当的蒸汽压,其中所述第一温度是所述抗菌剂的最高安全温度。
在一些实施方式中,所述溶剂包含乙醇且所述抗菌剂包含葡萄糖酸洗必泰。
在一些实施方式中,所述溶剂使得导管管体扩张以允许所述抗菌剂渗透进入所述导管管体中。
在另一个示例性实施方式中,本实用新型作为将抗菌涂层以图案的方式施用于导管管体的方法实施。抗菌涂层施用于导管管体的外表面。随后使导管管体经过模具以从所述外表面除去抗菌涂层的一部分,从而在导管管体通过模具后其外表面上保留抗菌涂层的图案。
在一些实施方式中,所述图案包含一个或多个抗菌涂层的条带。
在一些实施方式中,所述导管管体的外表面包含一个或多个通道,并且所述图案包含在所述一个或多个通道中的抗菌涂层。
在一些实施方式中,所述图案包含不包括所述抗菌涂层的外表面的一个或多个部分,或包含包括微量的抗菌涂层的外表面的一个或多个部分,以便透过所述一个或多个部分保持导管管体管腔中的内容物的能见度。
在一些实施方式中,所述图案顺应导管管体中含有的不透射线材料。
在一些实施方式中,所述模具在其内表面包括一个或多个通道。所述一个或多个通道形成所述图案。
在一些实施方式中,所述导管管体包含具有尖端的导管管体的区段,并且没有将所述抗菌涂层施用于所述尖端。
在一些实施方式中,在将所述抗菌涂层施用于所述导管管体的外表面之前,将轴芯插入到所述导管管体的一端以防止抗菌涂层进入所述末端。在一些实施方式中,该末端包含与所述导管管体上形成的尖端相对的末端。
在另一个示例性实施方式中,本实用新型作为包含具有周长的外表面的导管管体实施;并且将抗菌涂层以图案施用与外表面,其中所述图案没有覆盖外表面的整个周长。
在一些实施方式中,所述图案包含多个条带,其通过在外表面的整个周长施加抗菌涂层之后使导管管体经过模具而在外表面而形成。
在一些实施方式中,在外表面中的多个通道中形成所述多个条带。
在一些实施方式中,所述导管管体进一步包含不透射线材料制成的条带,所述不透射线材料制成的条带沿所述导管管体的长度的方向延伸,其中所述图案的多个条带与所述不透射线材料制成的条带基本平行。
在一些实施方式中,所述导管管体包含尖端,所述抗菌涂层没有延伸到所述尖端。
根据本实用新型的第一个实施方式,可以使用预处理工艺制造导管管体,先将抗菌涂层施用至导管管体,再施用润滑剂。在制造的各阶段使用该预处理工艺制造的导管管体100如图1A-1C所示。图1A展示了在施用抗菌涂层之前的导管管体100。导管管体100可以由适合于静脉内作为导管使用的任意材料制成,其中包括聚氨酯。
经过预处理工艺后,在导管管体100的外表面上形成了如图1B所示的抗菌涂层101。随后,如图1C所示,可以将润滑剂102施用至导管管体的抗菌涂层101上。当将导管管体100置于患者脉管系统中时,通过将润滑剂102施用至抗菌涂层101上,能够将抗菌涂层101中的抗菌剂的扩散限制到所需的速率。换言之,抗菌涂层101上存在的润滑剂102减慢了抗菌剂从涂层溶入血流的速率。这可以将由于在血液中浓度过量的抗菌剂造成的毒性可能性减到最低并延长涂层的有效寿命。
图2A-2D展示了将抗菌涂层101和润滑剂102施用至导管管体100的示例性方法。根据本实用新型的一个或多个实施方式,可以使用将溶液施用至导管管体外表面并使溶液中的溶剂挥发从而留下含有抗菌剂的涂层的方法将抗菌涂层101施用至导管管体100。
图2A展示了浸于含有溶剂和抗菌剂的溶液200中的导管管体100。图2A仅显示了浸入的导管管体100的一小部分;然而,应理解导管管体的大部分长度都可以同时地以这种方式处理。此外,尽管显示的导管管体100已经具有尖端,但是在一些实施方式中,可以在导管管体上或内部形成尖端或其他特性之前施用溶液200。另外,在一些实施方式中,可以塞住导管管体100的末端以防止溶液200进入管体的管腔。
在一些实施方式中,可以选择在溶液200中使用的溶剂和抗菌剂,以便在抗菌剂的最高安全温度下的溶剂的蒸汽压与大气压力大致相当或高于大气压力。以这种方式,可以获得适当的蒸发速率以保证抗菌涂层适当地形成。例如,溶液200可以包含乙醇和葡萄糖酸洗必泰(CHG),所述乙醇在80℃下具有大约800mmHg的蒸汽压(其与80℃下的大气压力接近),所述葡萄糖酸洗必泰可以在高达90℃下安全地使用。
在一些实施方式中,通过向导管管体100施用溶液200,溶液可以导致导管管体100扩张或膨胀。这种扩张增加了导管管体材料(例如聚合物如聚氨酯)的孔隙度,由此允许抗菌剂渗透进入材料。一旦溶剂从导管管体100蒸发,所述材料恢复至其正常尺寸,一定量的抗菌剂会留存在材料中并因此提供能够超过涂层有效期的抗菌特性,该涂层仅是在管体表面上。
回到附图,图2B展示了从溶液200中移出后的导管管体100。导管管体100的表面留存有一定量的溶液200,溶剂从其中蒸发。通过将导管管体100加热和/或置于降低的大气压力环境可以加速蒸发。如图2C所示,在将溶剂充分蒸发后,留有抗菌涂层101。
最后,如图2D所示,在形成抗菌涂层101后,可以施用(例如喷雾处理)润滑剂102至涂层上。润滑剂102除了在导管管体100和患者皮肤之间提供润滑外,还起到在抗菌涂层101上的临时密封胶的作用,以减慢涂层(或涂层内的抗菌剂)向周围液体如血液溶解的速率。
在一些实施方式中,润滑剂102也包含抗菌剂。在这种情况下,润滑剂102中的抗菌剂在导管管体100的插入位点提供了微生物屏障,在插入位点管体的插入可以引起过量的润滑剂的堆积。适宜的润滑剂包括如在美国专利公开号为2011/0065798,标题为医疗设备的抗感染润滑剂和制备其的方法(Anti-Infective Lubricant For Medical Devices AndMethods For Preparing The Same)文献,以及美国专利公开号为2011/0009831,标题为皮肤侵入性设备的抗菌涂层(Antimicrobial Coating for Dermally Invasive Devices)的文献中公开的那些,其均通过引用并入本申请。
根据本实用新型的第二个实施方式,可以将抗菌涂层以图案的方式施用于导管管体。可以有不同的原因需要以图案的方式施用涂层(与覆盖管体整个周长的连续涂层相反)。例如,许多涂层限制了导管管体管腔内的回流能见度。在这种情况下,可以以条带或其他不覆盖管体的整个周长的图案施用涂层,从而使导管管体的部分没有涂层,透过这些部分仍可以轻易地看见回流。另外,在高度拉抻导管管体时(这在制造外周静脉导管过程中是常见的),连续的涂层更容易被撕裂。在这种情况下,可以使用非连续的涂层将撕裂的可能性降到最低。
图3A-3C展示了如何将抗菌涂层301以条带图案施用至导管管体300的示例性实施方式。在这个示例中,导管管体300包括如图3A的透视图和图3B的剖视图中所示的不透射线条带305。可以将不透射线条带305整合入导管管体300以在x射线中提高导管管体300的能见度。为了保留导管管体300的一部分以透过其容易地看见回流,可以将抗菌涂层301以与不透射线条带305大体对齐排列的条带图案施用。
图3C展示了如何将抗菌涂层301以条带的方式施用于导管管体300的外表面上。如图所示,导管管体300包括抗菌涂层301的6个条带,所述条带与不透射线条带305大体对齐排列。以这种方式,在不透射线条带之间的导管管体300的部分不含或含有最少量的抗菌涂层301,以便透过这些部分不会限制回流的能见度。尽管抗菌涂层301的条带与不透射线条带305的宽度相似,但是可以根据需要增加或减少抗菌涂层的条带的宽度。
图4A-4C展示了如何将抗菌涂层301以条带的方式施用至导管管体400的另一种示例性的实施方式。导管管体400与导管管体300相似,除了导管管体400包括与不透射线条带405大体平行的通道406之外,如在图4B中的剖视图所示。可以在这些通道406之中使用抗菌涂层301,而导管管体400的外表面部分不含(或基本不含)抗菌涂层301以维持通过这些部分的回流能见度。
在图3A-3C和4A-4C展示的每个实施方式中,抗菌涂层301在导管管体的整个周长都不是连续的。因此,当拉抻导管时,抗菌涂层不容易被撕裂。例如,即使这些附图展示的导管管体已经具有尖端,但是在一些实施方式中,所述尖端可以在将抗菌涂层施用于管体后形成。在尖端形成过程中或在将导管与导管座固定的过程(如型锻)中,涂层的不连续图案会将涂层撕裂的可能性降到最低。
另外,在施用抗菌涂层后将导管管体进行热成型处理的情况下,抗菌涂层可以由热塑性粘合剂基质(如聚氨酯)组成,其在热成型处理过程中会允许涂层随导管管体变形。例如,通常使用热成型处理形成导管管体上的尖端。在这种情况下,抗菌涂层可以由热塑性粘合剂基质组成以允许抗菌涂层符合角度的尖端,从而所述尖端保留抗菌涂层。由此,即使图3A和4A暗示不会将抗菌涂层施用于尖端,但是不管所述尖端是在施用抗菌涂层之前或之后形成,本实用新型的技术使得施用抗菌涂层的图案更容易,所述抗菌涂层可以沿导管管体的主体以及尖端延伸。
图5A-5C展示了以条带图案的方式施用抗菌涂层的示例性过程。如图5A所示,模具580可以用于以需要的图案施用抗菌涂层。模具580包括许多通道501,所述通道501沿模具内表面方向延伸。如图5B所示,将通道501构造成能施用与如图3C所示的图案相似的图案(即与不透射线材料制成的条带大体平行的6个条带的图案)。
图5C展示了如何在将抗菌涂层301施用至管体外表面后将导管管体300穿过模具580。如图所示,将导管管体300浸于含有抗菌涂层301的溶液。随后,随着将导管管体300从溶液中拉出,使所述管体通过模具580。将模具580的内径构造成与导管管体300外径紧密贴合,以便模具580从所述管体的外表面擦去抗菌涂层。然而,由于模具580包括通道501,抗菌涂层301的6个条带会留在导管管体300的外表面。在一些实施方式中,在将抗菌涂层施用至导管管体后,可以加工处理所述涂层(例如使用热处理或紫外线处理)。
尽管图5C展示了当施用抗菌涂层时导管管体300已经包括了尖端,但是也可以在如上所述施用涂层后形成所述尖端。在这种情况下,通过使用热塑性粘合剂基质,所述抗菌涂层可以在热成型处理中重塑,从而所述条带可以符合尖端的成角度的表面。以这种方式,抗菌条带可以沿导管管体的整个长度延伸。
在导管管体包括通道的情况下,没有通道的模具(即具有圆形内径)可以用于擦除所有管体外表面的抗菌涂层,从而仅在通道中留有涂层。此外,还可以使用具有形成不同图案的通道的模具。例如,可以使用比模具580具有更多或更少的通道的模具或具有不同宽度或深度的通道的模具。另外,当导管管体通过模具时可以转动模具(或导管管体)以施用螺旋图案。由此,本发明扩展出不同类型的抗菌涂层图案。
尽管图3A-3C、4A-4C和5A-5C展示了将涂层施用于包括不透射线条带的导管管体上,但是以图案的方式施用涂层的技术可以等同地用于不包括不透射线材料的导管管体上。例如,即使其各自不含有不透射线条带305和405,也可以施用相同的图案至导管管体300和导管管体400。
使用模具施用图案的技术通常可以用于导管管体的大部分长度。例如,可以将足以用于生产许多导管的长度的导管管体浸于含有抗菌剂301的溶液,随后使之通过模具580。然后可以将导管管体切割成所需长度的区段并在区段上形成尖端。在这些情况下,可能需要使用由热塑性粘合剂基质组成的抗菌涂层,因为使用热成型处理形成尖端是很常见的。
然而,在一些情况下,需要使用由不能被热重塑的热固性聚合物组成的抗菌涂层。由于这些涂层无法被热重塑,需要在施用抗菌涂层之前形成具有尖端的区段。
图6A和6B展示了如何将抗菌涂层施用于导管管体区段的示例性实施方式,以便所述涂层如图6A所示不会沿尖端延伸。由于上述工艺包括将导管管体浸于包含抗菌涂层的溶液,一定量的抗菌涂层会进入导管管体管腔中,在管体内表面形成涂层。当在切割之前处理较长管长的导管管体时,这不是问题,因为可以切除管体末端以去除内表面上具有的涂层的管体的任意部分。相反,当首先将导管管体切割成区段并在接受抗菌涂层之前形成尖端时,需要防止涂层进入到区段的管腔中。
图6B展示了如何使用与如图5A-5C所示的方法相似的方法将抗菌涂层的图案施用于导管管体600的区段上,同时防止涂层进入区段的管腔中且不在尖端施用涂层。如图所示,在将区段600浸于含有抗菌涂层的溶液之前,将轴芯670插入到区段600中与尖端相对的末端。随后将所述区段轴芯末端首先浸入到溶液中,同时防止尖端被浸没。使所述区段通过模具680以去除多余的抗菌涂层并保留需要的图案。随后可以移除所述轴芯。
在一些实施方式中,除了移除轴芯,还可以首先将区段切割为比所需长度稍长的长度,以便切除区段中含有轴芯的部分。在轴芯切除后获得的区段的长度可以是导管管体所需的长度。
在一些实施方式中,可以在形成图案的实施方式中使用如美国专利公开号为2010/0135949,标题为抗菌涂层(Antimicrobial Coatings)(其通过引入并入)的文献所描述的抗菌涂层的制剂。在一个具体的示例中,可以使用这种制剂施用于聚氨酯导管管体,并通过使用紫外线固化以形成抑制生物膜生长的洗必泰洗脱层。
实施例
实施例1:抑菌圈试验
通过将规格20x 1.25英寸的导管浸于由5%CHG、20%水和75%乙醇组成的溶液,预处理导管以形成抗菌涂层。将所述经涂覆的导管干燥2分钟。随后用含有0.5%CHG w/w的硅胶润滑剂乳液对经涂覆的导管喷雾处理。将没有经过预处理的导管用相同的润滑剂乳液喷雾处理。随后将经过和没有经过预处理的导管的小区段用于抑菌圈(ZOI)试验。经预处理的导管显示出针对表皮葡萄球菌有19mm的ZOI,而未经预处理的导管仅显示出1.5mm的ZOI。
在不脱离其精神或主要特征的情况下,本发明可以以其他具体的形式体现。本发明描述的实施方式旨在在所有方面仅以示例性而非限制性的方式考虑。因此,本发明的范围由所附的权利要求而非之前的说明书表明。在与权利要求的等同替换的意义和范围内的所有变化都包括在权利要求的范围内。
Claims (5)
1.一种导管管体,其特征在于,所述导管管体包括:
具有周长的外表面;和
抗菌涂层,所述抗菌涂层被施加到所述外表面,从而形成不覆盖所述外表面的整个周长的图案。
2.根据权利要求1所述的导管管体,其特征在于,其中所述图案包含多个条带,通过在所述外表面的整个周长施加所述抗菌涂层之后使所述导管管体经过模具,在所述外表面形成所述多个条带。
3.根据权利要求2所述的导管管体,其特征在于,其中在所述外表面中的多个通道中形成所述多个条带。
4.根据权利要求2所述的导管管体,其特征在于,其中所述导管管体进一步包含由不透射线材料制成的条带,所述不透射线材料制成的条带沿所述导管管体长度的方向延伸,其中所述图案的多个条带与所述不透射线材料制成的条带基本平行。
5.根据权利要求1所述的导管管体,其特征在于,其中所述导管管体包含尖端,所述抗菌涂层没有延伸到所述尖端。
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US14/260,056 | 2014-04-23 | ||
US14/260,056 US9675793B2 (en) | 2014-04-23 | 2014-04-23 | Catheter tubing with extraluminal antimicrobial coating |
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CN105412995A (zh) * | 2015-12-04 | 2016-03-23 | 江苏道森新材料有限公司 | 医用导管及其表面形成抗菌亲水涂层的方法 |
CN111514432A (zh) * | 2019-02-02 | 2020-08-11 | 江苏百赛飞生物科技有限公司 | 微导管及其制备方法和包括其的医疗器械 |
CN111514432B (zh) * | 2019-02-02 | 2021-06-08 | 江苏百赛飞生物科技有限公司 | 微导管及其制备方法和包括其的医疗器械 |
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