CN108211068A - 一种医用防菌润滑功能的t型气管插管及其制备方法 - Google Patents

一种医用防菌润滑功能的t型气管插管及其制备方法 Download PDF

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CN108211068A
CN108211068A CN201810057127.5A CN201810057127A CN108211068A CN 108211068 A CN108211068 A CN 108211068A CN 201810057127 A CN201810057127 A CN 201810057127A CN 108211068 A CN108211068 A CN 108211068A
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陈怀文
郑宏良
杨冬梅
张才云
陈东辉
陈世彩
朱敏辉
高颖娜
董银梅
李孟
贺智明
王凤英
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Shanghai Shi Yu Biotechnology Co Ltd
Shanghai Changhai Hospital
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Shanghai Changhai Hospital
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Abstract

本发明公开了一种医用具有润滑抗菌功能的T型气管插管，以硅烷偶联剂将羧甲基壳聚糖连接于气管插管表面，形成表面抗菌涂层，进一步表面交联亲水材料聚(2‑乙基‑2‑噁唑啉)，制备成润滑抗菌性能的T型气管插管。本发明的T型气管插管可以减轻放置过程对患者喉部的气道损伤；同时，适于降低插管长期滞留气道引发细菌感染的风险，提升气管插管患者的治疗顺应性。

Description

一种医用防菌润滑功能的T型气管插管及其制备方法
技术领域
本发明涉及一种医用防菌润滑功能的气管插管，具体为壳聚糖及亲水材料涂层改性的T型气管插管及其制备方法
背景技术
目前医用喉部气管切开插管大多数由疏水性硅橡胶材料制造，虽然它拥有优良的机械性能和生物相容性能，但作为疏水性材料，在介入人体时对组织的摩擦力较大，易损伤喉部气道、血管壁等上皮组织，有疼痛或灼伤感,且容易吸附细菌引起并发炎症，尤其在放入和取出插管过程中，会给患者带来显著的阵痛与损伤。
医用疏水材料的表面增加亲水涂层改性，比如聚乙烯毗咯烷酮(PVP)、聚丙烯酞胺(PMMA)等高分子涂层，可以极大降低介入导管表面的摩擦系数提高润滑性能。然而这种涂层厚度不易控制，血液相容性方面优势有限。亲水高分子材料聚(2-乙基-2-噁唑啉)细胞毒性极低，分子链状结构，柔性好，多用于药物或载体材料表面修饰，可以有效提高修饰物的亲水润滑性。重要的是，聚(2-乙基-2-噁唑啉)分子通过空间排斥效应，可以有效阻止血液中的大分子如血浆蛋白、血小板等在材料表面的粘附，是一种血液相容性良好的亲水涂层材料。
壳聚糖是一种良好的生物医用材料，具有诸多医用功能：如抗菌、止血、止痛、促进修复等，壳聚糖的抗菌效果已得到广泛认可。其抗菌机理尚处在深入研究中，但主要与壳聚糖的氨基电性有关。该材料已用于医用材料的抗菌涂层修饰研究，但如何以最安全处理方式实现并且长期留存医用材料表面于仍在不多探索之中。利用水溶性羧甲基壳聚糖中活跃的羧基实现与医用材料共价连接，是较为可行的安全环保手段。同时，亲水高分子材料的交联也会减少壳聚糖涂层的脱落。
发明内容
本发明旨在提供一种防菌润滑功能的T型气管插管，可同时提高插管的润滑性，减轻气管插入带给患者的痛苦，又减少因插管长期滞留可能引发的细菌感染。该T型气管插管表面修饰有壳聚糖连接涂层和亲水材料聚(2-乙基-2-噁唑啉)交联涂层。
所述的防菌润滑功能的T型气管插管，其制备方法步骤如下。
1）插管表面活化：将T型气管插管分别通过乙醇溶液、去离子水溶液超声清洗20min后；将T型气管插管置于氨基活性硅烷偶联剂溶液中一定时间，反复处理3 ~ 5次后取出干燥。
2）制备羧甲基壳聚糖修饰的T型气管插管：称取羧甲基壳聚糖，搅拌溶解于醋酸-醋酸钠缓冲溶液中，加入一定浓度的催化偶联剂后，将步骤1）处理的T型气管插管放置于该溶液，在4℃条件下静置过夜，使羧甲基壳聚糖与氨基基团偶联，进而连接于插管表面。
3）聚(2-乙基-2-噁唑啉)亲水涂层处理：将步骤2）处理的T型气管插管放置于含有聚(2-乙基-2-噁唑啉)的乙醇溶液中，浸泡并烘干，反复数次，形成具有防菌润滑功能的T型气管插管。
在步骤1）中，所述T型气管插管的材质为硅橡胶或聚氨醋；所述氨基活性硅烷偶联剂，包括且不限于：氨丙基三乙氧基硅烷、氨丙基三甲氧基硅烷、2-氨乙基-氨丙基三甲氧基硅烷、氨乙基-氨丙基甲基二甲氧基硅烷。
在步骤2）中，所述壳聚糖为羧甲基壳聚糖，包括：N-羧甲基壳聚糖、O-羧甲基壳聚糖、N,O-羧甲基壳聚糖，其羧基化度为70 ~ 90%，其分子量为9000~50000；所述醋酸-醋酸钠缓冲溶液的PH范围为5.5 ~ 6.5；所述壳聚糖在醋酸-醋酸钠缓冲溶液中浓度范围为50 ~200mg/ml；所述催化偶联剂为N,N-二环己基碳二亚胺(DCC)；所述催化偶联剂采用浓度为10~ 30mM。
在步骤3）中，所述聚(2-乙基-2-噁唑啉)的分子量范围为5000 ~ 30000；所述聚(2-乙基-2-噁唑啉)乙醇溶液的浓度不低于10mg/ml。
本发明的有利之处是：本发明将壳聚糖连接于T型气管插管表面，并进一步交联亲水高分子材料聚(2-乙基-2-噁唑啉)涂层，使其具有良好的亲水润滑效果，有效降低了插管损伤。更重要的，插管表面的壳聚糖涂层通过化学酰胺键连接以及亲水材料的交联，可以留存于插管表面，延长了抗菌周期。相比光交联、辐射交联引入潜在毒害物质，本发明防菌润滑功能气管的插管制备方法经济环保、安全有效、适于大规模应用。
附图说明
图1为本发明医用防菌润滑功能的T型气管插管的制备方法示意图。
图2为气管插管经过壳聚糖连接涂层及亲水材料交联涂层处理前后的T型气管插管的表面水接触角照片。
图3为在体外浸泡实验中各组水接触角值变化曲线。A组为壳聚糖连接涂层及亲水材料交联涂层处理的插管； B组为仅亲水材料交联涂层处理的插管；C组为仅壳聚糖连接涂层处理的插管。
具体实施方式
下面通过具体的实施例子对本发明进行详细说明。
实施例一：将硅橡胶T型气管插管两端密封，放入500ml的50%乙醇溶液中超声清洗20min，再用高纯水超声清洗除尽插管表面杂质异物,后置于温控干燥箱中40℃烘干备用。
实施例二：将10ml的2-氨乙基-氨丙基三甲氧基硅烷加入到50ml的25%乙醇溶液中,用少量冰乙酸调节溶液PH值,静置待偶联剂溶液完全澄明，将实施例一中清洗干净的T型气管插管浸泡于连接涂层溶液中，60秒后缓慢提拉出液面，反复处理3 ~ 5次，以热风机烘干，完成硅烷偶联剂的管壁涂布。
实施例三：称取分子量为35KD的水溶性O-羧甲基壳聚糖50mg，搅拌溶解于500ml的醋酸-醋酸钠缓冲溶液（PH=5.5）中，加入N,N-二环己基碳二亚胺(DCC)至浓度为10mM。缓慢放入实施例二中涂布硅烷偶联剂的T型气管插管，在4℃条件下静置过夜，取出后去离子水润洗数次，获得表面偶联壳聚糖的T型气管插管。
实施例四：称取5g分子量20KD的) 聚(2-乙基-2-噁唑啉)分散于500ml的35%乙醇溶液中，超声分散至溶液完全澄明, 即亲水涂层溶液。将以上实施例三壳聚糖表层的T型气管插管浸泡于该亲水涂层溶液中，缓慢轻摇插管20min后缓慢提拉出液面，以热风机烘干，如此反复3次，使偶联壳聚糖的T型气管插管表面交联聚(2-乙基-2-噁唑啉)亲水涂层，即得防菌润滑功能的T型气管插管（图1）。
实施例五：固定以上获得的防菌润滑功能气管插管和未经处理插管样品，保证在接触角测量过程中不会发生滚动，垂直滴加2μl水滴于样品表面，注静止后测量拍照，每组取样三个，每个样品随机测三个点，采用高速视频光学接触角测量仪测定水滴与样品表面的接触角大小，记录数据并取其平均值作为测试结果，如图所示图2。
实施例六：将经过实例一至四处理后插管样品以及对照组各6只，分别浸泡于盛有500ml纯净水溶液中，在37℃下恒温振荡条件下,浸泡时间分别为0、7、14、21、28、35天，每天换液一次，到达预定时间后将样品取出，经热风机干燥后,测量其水接触角值。结果证实：在体外浸泡条件下，偶联羧基化壳聚糖的T管的接触角始终不超过30°，说明本发明的插管可以长期保持插管的亲水性，而仅仅交联聚(2-乙基-2-噁唑啉)高分子的插管接触角会逐渐变大，说明其亲水性降低（图3）。
实施例七：将实施例六终点的T型气管插管浸泡于盛有100ml醋酸钠缓冲溶液（pH5.5）的烧杯中，加入5ml茚三酮溶液并加热煮沸，发现气管插管表面溶液颜色变为紫色，该结果说明经过长期的留滞处理壳聚糖仍保持在插管表面。

Claims (10)

1.一种医用防菌润滑功能的T型气管插管，其特征在于：该T型气管插管表面修饰有壳聚糖连接涂层和亲水材料聚(2-乙基-2-噁唑啉)交联涂层；
所述的防菌润滑功能的T型气管插管，其制备方法步骤如下：
1）插管表面活化：将T型气管插管分别通过乙醇溶液、去离子水溶液超声清洗20min后；将T型气管插管浸泡于氨基活性硅烷偶联剂溶液中一定时间，反复处理3 ~ 5次后取出干燥；
2）制备羧甲基壳聚糖修饰的T型气管插管：称取羧甲基壳聚糖，搅拌溶解于醋酸-醋酸钠缓冲溶液中，加入一定浓度的催化偶联剂后，将步骤1）处理的T型气管插管放置于该溶液，在4℃条件下静置过夜，使羧甲基壳聚糖与氨基基团偶联，进而连接于插管表面；
3）聚(2-乙基-2-噁唑啉)亲水涂层处理：将步骤2）处理的T型气管插管放置于含有聚(2-乙基-2-噁唑啉)的乙醇溶液中，浸泡并烘干，反复数次，形成具有防菌润滑功能的T型气管插管。
2.如权利要求1所述的防菌润滑功能的T型气管插管，其特征在于步骤1）中，所述T型气管插管的材质为硅橡胶或聚氨醋。
3.如权利要求1所述的防菌润滑功能的T型气管插管，其特征在于步骤1）中，所述氨基活性硅烷偶联剂，包括且不限于：氨丙基三乙氧基硅烷、氨丙基三甲氧基硅烷、2-氨乙基-氨丙基三甲氧基硅烷、氨乙基-氨丙基甲基二甲氧基硅烷。
4.如权利要求1所述的防菌润滑功能的T型气管插管，其特征在于步骤2）中，所述壳聚糖为羧甲基壳聚糖，包括：N-羧甲基壳聚糖、O-羧甲基壳聚糖、N,O-羧甲基壳聚糖，其羧基化度为70 ~ 90%，其分子量为9000 ~ 50000。
5.如权利要求1所述的防菌润滑功能的T型气管插管，其特征在于步骤2）中，所述醋酸-醋酸钠缓冲溶液的PH范围为5.5 ~ 6.5。
6.如权利要求1所述的防菌润滑功能的T型气管插管，其特征在于步骤2）中，所述壳聚糖在醋酸-醋酸钠缓冲溶液中浓度范围为50 ~ 200mg/ml。
7.如权利要求1所述的防菌润滑功能的T型气管插管，其特征在于步骤2）中，所述催化偶联剂为N,N-二环己基碳二亚胺(DCC)。
8.如权利要求1所述的防菌润滑功能的T型气管插管，其特征在于步骤2）中，所述催化偶联剂采用浓度为10 ~ 30mM。
9.如权利要求1所述的防菌润滑功能的T型气管插管，其特征在于步骤3）中，所述聚(2-乙基-2-噁唑啉)的分子量范围为5000 ~ 30000。
10.如权利要求1所述的防菌润滑功能的T型气管插管，其特征在于步骤3）中，所述聚(2-乙基-2-噁唑啉)在乙醇溶液的浓度不低于10mg/ml。
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