CN117281958A - 一种医用导管涂料及其应用 - Google Patents
一种医用导管涂料及其应用 Download PDFInfo
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- 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
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
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- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
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Abstract
本发明属于医疗器械领域,具体涉及一种医用导管涂料。该医用导管涂料包括如下总量份数的组分:改性Cu‑ZnO纳米颗粒10~15份;水性PUA树脂25~35份;活性稀释剂10~25份;表面活性剂1~1.5份;光引发剂1~2份;助剂0.5~1份;去离子水10~20份;甲醇和/或乙醇40~60份。本发明提供的涂料具有较好的亲水性,能够降低导管与人体组织之间的摩擦力,且具有较高的抗菌性。
Description
技术领域
本发明属于医疗器械领域,具体涉及一种医用导管涂料及其应用。
背景技术
医用导管应用于各种疾病的治疗和诊断过程中,需要与人体组织、血液、体液接触,有的甚至需要长时间植入体内,因此对医用导管的生物相容性和抗菌性能有着极高的要求,进而对医用导管的表面改性来获取生物相容性和抗菌性能有着重大意义。
目前市场上常见的医用导管材料为聚氯乙烯(PVC)、聚氨酯(PUA)和硅橡胶(SR),这些材料通常表面都是疏水。在导入体内时摩擦力较大,病人常伴有灼烧和疼痛感,造成血管等组织的损伤甚至引发炎症;同时在导管表面可能粘附的细菌导致病人的感染。临床上通常的解决办法是导管的外表面涂抹一层润滑剂来降低导管与人体组织之间的摩擦力,但这种方法改善效果不佳,耐久性差且操作繁琐,在使用上受到限制。
发明内容
针对现有技术的缺陷,本发明的目的在于提供一种医用导管涂料,该涂料具有较好的亲水性,能够降低导管与人体组织之间的摩擦力,且具有较高的抗菌性。
该医用导管涂料包括如下总量份数的组分:
进一步地,所述活性稀释剂选自PEG200DA,PEG300DA,PEG400DA和季戊四醇三丙烯酸酯中的一种或者多种。
进一步地,所述表面活性剂选自聚乙烯吡络烷酮K30、聚乙烯吡络烷酮K60和聚乙烯吡络烷酮K90一种或多种。
进一步地,所述光引发剂选自光引发剂2959、光引发剂TPO和光引发剂1173D中的一种或多种。
进一步地,所述助剂包括抗氧化剂和阻聚剂。
进一步地,所述抗氧化剂选自抗氧剂168,所述阻聚剂选自阻聚剂510。
进一步地,所述改性Cu-ZnO纳米颗粒通过以下方法制备:
(1)ZnO纳米颗粒的改性:将ZnO NPs加入到无水乙醇中超声分散,分散完全后加入硅烷偶联剂,再次搅拌后加入催化剂,在40~60℃条件下继续反应2~3h,随后清洗,保存在无水乙醇中待用。
(2)改性Cu-ZnO纳米颗粒制备:将改性ZnO纳米颗粒分散在去离子水中超声分散,待分散完全后加入CuCl2·2H2O,升温80℃后缓慢加入还原剂,继续反应16~24h得到改性Cu-ZnO纳米颗粒,采用无水乙醇和去离子水清洗后待用。
进一步地,所述水性PUA树脂通过以下方法制备:
第一步:加入反应单体丙烯酸羟乙酯(HEA)和异佛尔酮二异氰酸酯(IPDI),搅拌均匀后加入催化剂和抗氧化剂,在30~50℃条件下反应2~4小时;
第二步,在第一步完成后加入PEG继续反应,其中二者官能团摩尔比为-NCO:-OH为2:1,再次加入同样质量比例的催化剂和抗氧剂,在60~80℃条件下反应3~5小时制备得到水性PUA树脂。
本发明还提供了一种如上所述的医用导管涂料在医用导管中的应用。
本发明与现有技术相比,本发明具有如下的有益效果:
1)大多数医用导管为聚氨酯材料,因此涂料中的水性PUA树脂在提供涂层超亲水性的同时还可以有效提升涂层与导管管壁之间的结合力。
2)采用硅烷偶联剂修饰ZnO纳米颗粒,可以在ZnO纳米颗粒表面提供双键反应位点,在UV固化时可以参与反应,更好的将Cu-ZnO纳米颗粒固定在涂层中。
3)用KH-570修饰ZnO纳米颗粒后,再在其表面生成Cu颗粒,Cu颗粒的引入一方面可以更好的提升ZnO纳米颗粒的抗菌性能,另一方面,可以进一步固定ZnO纳米颗粒表面修饰的硅烷偶联剂,使其不会再后期使用过程中出现修饰脱落的问题。
4)ZnO纳米颗粒具有优异的抗菌性能,但其在黑暗条件下的抗菌活性较弱,在ZnO纳米颗粒表面引入Cu颗粒可以有效解决这一问题,Cu-ZnO纳米颗粒具有高效的抗菌性能。
5)在涂层中引入表面活性剂,可以进一步提升涂层本身的亲水性能,另一方面在导管接触人体组织时可以起到润滑作用。
附图说明
图1为本发明提供的改性Cu-ZnO纳米颗粒的制备方法。
图2为本发明提供的水性PUA树脂的制备方法。
具体实施方式
为了使本发明的上述目的、特征和优点能够更加明显易懂,下面结合附图对本发明的具体实施方式做详细的说明,但不能理解为对本发明的可实施范围的限定。
本发明提供一种医用导管涂料,包括如下总量份数的组分:
可选地,活性稀释剂选自PEG200DA,PEG300DA,PEG400DA和季戊四醇三丙烯酸酯中的一种或者多种。
可选地,表面活性剂选自聚乙烯吡络烷酮K30、聚乙烯吡络烷酮K60和聚乙烯吡络烷酮K90一种或多种。在涂层中引入表面活性剂,可以进一步提升涂层本身的亲水性能,另一方面在导管接触人体组织时可以起到润滑作用。
可选地,光引发剂选自光引发剂2959、光引发剂TPO和光引发剂1173D中的一种或多种。采用复合光引发剂可以提升涂料的固化效率,缩短成膜时间。
可选地,助剂包括抗氧化剂和阻聚剂,抗氧化剂选自抗氧剂168,阻聚剂选自阻聚剂510。
甲醇或乙醇有利促进各组分的相容性。
本发明先用硅烷偶联剂修饰ZnO纳米颗粒,再在其表面生成Cu颗粒。采用硅烷偶联剂修饰ZnO纳米颗粒,可以在ZnO纳米颗粒表面提供双键反应位点,在UV固化时可以参与反应,更好的将Cu-ZnO纳米颗粒固定在涂层中。Cu颗粒的引入一方面可以更好的提升ZnO纳米颗粒的抗菌性能,改善ZnO纳米颗粒在黑暗条件下的抗菌活性较弱的问题,另一方面可以进一步固定ZnO纳米颗粒表面修饰的硅烷偶联剂,使其不会再后期使用过程中出现修饰脱落的问题。
参阅图1,改性Cu-ZnO纳米颗粒制备过程如下:
(1)ZnO纳米颗粒的改性:将ZnO NPs加入到无水乙醇中超声分散,分散完全后加入硅烷偶联剂,再次搅拌后加入催化剂,在40~60℃条件下继续反应2~3h,随后清洗,保存在无水乙醇中待用。
(2)改性Cu-ZnO纳米颗粒制备:将改性ZnO纳米颗粒分散在去离子水中超声分散,待分散完全后加入CuCl2·2H2O,升温80℃后缓慢加入还原剂,继续反应16~24h得到改性Cu-ZnO纳米颗粒,采用无水乙醇和去离子水清洗后待用。
参阅图2,水性PUA树脂由两步反应合成方法包括以下步骤:
第一步:加入反应单体丙烯酸羟乙酯(HEA)和异佛尔酮二异氰酸酯(IPDI),搅拌均匀后加入催化剂和抗氧化剂,在30~50℃条件下反应2~4小时;
第二步,在第一步完成后加入PEG继续反应,其中二者官能团摩尔比为-NCO:-OH为2:1,再次加入同样质量比例的催化剂和抗氧剂,在60~80℃条件下反应3~5小时制备得到水性PUA树脂。
大多数医用导管为聚氨酯材料,因此涂料中的水性PUA树脂在提供涂层超亲水性的同时还可以有效提升涂层与导管管壁之间的结合力。
实施例1
一种医用导管涂料,包括如下重量份数原料:
涂料的配制方法:将上述原料依次加入500mL的三口烧杯中,在50℃水浴中边超声边搅拌30min,超声功率50%,搅拌速率300rpm。
亲水涂层制备:将500μL的涂料原液滴在5×5×2mm的PUA板上,待涂料自动流平后倾斜静置2分钟,随后后放入60℃的烘箱预烘5min,随后进行UV光固化,固化能量为50000mJ/cm2。
实施例2
一种医用导管涂料,包括如下重量份数原料:
涂料的配制方法:将上述原料依次加入500mL的三口烧杯中,在50℃水浴中边超声边搅拌30min,超声功率50%,搅拌速率300rpm。
亲水涂层制备:将500μL的涂料原液滴在5×5×2mm的PUA板上,待涂料自动流平后倾斜静置2分钟,随后后放入60℃的烘箱预烘5min,随后进行UV光固化,固化能量为50000mJ/cm2。
实施例3
一种医用导管涂料,包括如下重量份数原料:
涂料的配制方法:将上述原料依次加入500mL的三口烧杯中,在50℃水浴中边超声边搅拌30min,超声功率50%,搅拌速率300rpm。
亲水涂层制备:将500μL的涂料原液滴在5×5×2mm的PUA板上,待涂料自动流平后倾斜静置2分钟,随后后放入60℃的烘箱预烘5min,随后进行UV光固化,固化能量为50000mJ/cm2。
对比例1
一种医用导管涂料,包括如下重量份数原料:
涂料的配制方法:将上述原料依次加入500mL的三口烧杯中,在50℃水浴中边超声边搅拌30min,超声功率50%,搅拌速率300rpm。
亲水涂层制备:将500μL的涂料原液滴在5×5×2mm的PUA板上,待涂料自动流平后倾斜静置2分钟,随后后放入60℃的烘箱预烘5min,随后进行UV光固化,固化能量为50000mJ/cm2。
对比例2
一种医用导管涂料,包括如下重量份数原料:
涂料的配制方法:将上述原料依次加入500mL的三口烧杯中,在50℃水浴中边超声边搅拌30min,超声功率50%,搅拌速率300rpm。
亲水涂层制备:将500μL的涂料原液滴在5×5×2mm的PUA板上,待涂料自动流平后倾斜静置2分钟,随后后放入60℃的烘箱预烘5min,随后进行UV光固化,固化能量为50000mJ/cm2。
本发明中,不同种类水性PUA树脂对实验结果无明显差异。
性能测试:
对实施例1~3和对比例1~2进行涂膜性能测试,测试初始防雾性能,浸泡后防雾性能,水接触角,硬度,附着力,耐磨性能。
具体性能测试项目及对应方法如下:
一、水接触角测试:
在固化膜表面滴2.5μL的超纯水,在室温下采用接触角测量仪进行测试。
二、附着力测试:
采用白格法,用3M不干胶带对样品附着力进行测试;
估评方法:
0级-划线边缘光滑,在划线的边缘及交叉点处均无漆膜脱落;
1级-在划线的交叉点处有小片漆膜脱落,但脱落面积小于5%;
2级-在划线的边缘及交叉点处有小片漆膜脱落,但脱落面积在5~15%之间;
3级-在划线的边缘及交叉点处有成片漆膜脱落,但脱落面积在15~35%之间;
4级-在划线的边缘及交叉点处有成片漆膜脱落,但脱落面积在35~65%之间;
5级-在划线的边缘及交叉点处有成片漆膜脱落,但脱落面积大于65%。
三、抗菌性测试:
按照GB/T 21866-2008《抗菌涂料(漆膜)抗菌性测定法和抗菌效果》规定的抗菌实验方法测试,通过平板计数法测定细菌菌落的增殖情况对涂层的抗菌性能进行评价,选取革兰氏阳性菌(ATCC 547)和革兰氏阴性菌(ATCC 1555)作为目标试验菌种。
表1实施例1-5的性能参数比较
结果分析:
实施例1和实施例2相比,实施例2由使用的活性稀释剂由PEG200DA更换为PEG400DA,涂料的组分配比,尤其是纳米颗粒的比例稍有增加,导致水接触角的微小差异,这种差异在宏观涂料性能尺度上一般视为一致(<10°),对润滑的功能性影响很小。
实施例1和实施例3相比,使用的单体从PEG200DA更换为季戊四醇三丙烯酸酯,使得实施例3的涂层水接触角低于实施例1。
对比例1和实施例3相比,纳米颗粒未进行改性引入铜元素,导致最终涂层的抗菌性弱于实施例3中使用的改性Cu-ZnO纳米颗粒。
对比例2和实施例1相比,涂料中不包括改性Cu-ZnO纳米颗粒,因此制备的涂层不具有抗菌性。
Claims (9)
1.一种医用导管涂料,其特征在于,包括如下总量份数的组分:
2.如权利要求1所述的医用导管涂料,其特征在于,所述活性稀释剂选自PEG200DA,PEG300DA,PEG400DA和季戊四醇三丙烯酸酯中的一种或者多种。
3.如权利要求1所述的医用导管涂料,其特征在于,所述表面活性剂选自聚乙烯吡络烷酮K30、聚乙烯吡络烷酮K60和聚乙烯吡络烷酮K90一种或多种。
4.如权利要求1所述的医用导管涂料,其特征在于,所述光引发剂选自光引发剂2959、光引发剂TPO和光引发剂1173D中的一种或多种。
5.如权利要求1所述的医用导管涂料,其特征在于,所述助剂包括抗氧化剂和阻聚剂。
6.如权利要求5所述的医用导管涂料,其特征在于,所述抗氧化剂选自抗氧剂168,所述阻聚剂选自阻聚剂510。
7.如权利要求1所述的医用导管涂料,其特征在于,所述改性Cu-ZnO纳米颗粒通过以下方法制备:
(1)ZnO纳米颗粒的改性:将ZnO NPs加入到无水乙醇中超声分散,分散完全后加入硅烷偶联剂,再次搅拌后加入催化剂,在40~60℃条件下继续反应2~3h,随后清洗,保存在无水乙醇中待用;
(2)改性Cu-ZnO纳米颗粒制备:将改性ZnO纳米颗粒分散在去离子水中超声分散,待分散完全后加入CuCl2·2H2O,升温80℃后缓慢加入还原剂,继续反应16~24h得到改性Cu-ZnO纳米颗粒,采用无水乙醇和去离子水清洗后待用。
8.如权利要求1所述的医用导管涂料,其特征在于,所述水性PUA树脂通过以下方法制备:
第一步:加入反应单体丙烯酸羟乙酯(HEA)和异佛尔酮二异氰酸酯(IPDI),搅拌均匀后加入催化剂和抗氧化剂,在30~50℃条件下反应2~4小时;
第二步,在第一步完成后加入PEG继续反应,其中二者官能团摩尔比为-NCO:-OH为2:1,再次加入同样质量比例的催化剂和抗氧剂,在60~80℃条件下反应3~5小时制备得到水性PUA树脂。
9.如权利要求1所述的医用导管涂料在医用导管中的应用。
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