CN117442788A - 一种介入导管表面改性方法 - Google Patents
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Abstract
本发明公开了一种介入导管表面改性方法,其包括以下步骤:S1:利用聚氨酯颗粒制备导管,导管清洗后干燥;S2:将丙烯酸与丙烯酰胺加入醋酸水溶液配成混合液;S3:向混合液中加入壳聚糖与过硫酸铵反应合成预聚物;S4:向预聚物中加入2,5‑二甲基‑2,5‑二(叔丁基过氧化)己烷,并在紫外灯照射下,制备出高分子水凝胶;S5:把导管浸入到水凝胶溶液中;S6:当紫外光照射器温度升到60‑70℃,通入氮气后把S5中的水凝胶溶液转移到紫外光照射器,用紫外光照射;照射时间优选为60min。S7:取出导管后清洗干燥。本发明改善了导管的润滑性,从而降低摩擦系数,同时还能改善导管表面的血液相容性和抗菌性。
Description
技术领域
本发明涉及医疗器械技术领域,具体涉及到一种介入导管表面改性方法。
背景技术
介入导管材料作为生物医学材料,必须满足生物医学应用的条件。目前,生物医用材料通常是指能够直接与生理系统接触,对细胞、组织、器官进行相互作用、诊断、替代、修复或诱导再生的一类天然或人工合成的特殊功能材料。医用介入导管的使用性能取决于其制造材料,其使用效果与病人的感受息息相关,作为最常用的介入治疗器材之一,介入导管的材料选择必须小心谨慎。作为医用介入导管材料其性能必须满足以下基本条件:具有优异的生物相容性、具有良好的机械性能、具有良好的亲水润滑性、具有良好的加工性能。如何提升介入导管的综合性能,一直是本领域的研发重点。
发明内容
本发明提供一种通过紫外光接枝的方法在聚氨酯导管表面接枝聚合亲水性涂层,改善其润滑性,从而降低摩擦系数,改善材料的血液相容性和抗菌性,提高导管的综合性能。具体技术方案如下。
一种介入导管表面改性方法,其特征在于,包括以下步骤:
S1:利用聚氨酯颗粒制备导管,导管清洗后干燥;
S2:将丙烯酸与丙烯酰胺加入醋酸水溶液配成混合液;
S3:向混合液中加入壳聚糖与过硫酸铵反应合成预聚物;
S4:向预聚物中加入2,5-二甲基-2,5-二(叔丁基过氧化)己烷,并在紫外灯照射下,制备出高分子水凝胶;
S5:把导管浸入到水凝胶溶液中;
S6:当紫外光照射器温度升到60-70℃,通入氮气后把S5中的水凝胶溶液转移到紫外光照射器,用紫外光照射;照射时间优选为60min。
S7:取出导管后清洗干燥。
进一步地,所述步骤S2中,丙烯酸与丙烯酰胺的物质的量相同。
进一步地,所述醋酸水溶液为2%醋酸水溶液。
进一步地,所述步骤S4中,2,5-二甲基-2,5-二(叔丁基过氧化)己烷占预聚物质量的1%-1.8%。
进一步地,所述步骤S6中,氮气的通气时间为8-10min;紫外光照射60min,导管与紫外灯的距离为18-20cm。
进一步地,所述步骤S7中,用乙醇超声清洗7-8h,然后在水中清洗24h,随后放入60-70℃干燥箱中干燥,直至重量不再发生变化。
壳聚糖(CS)是一种具有独特分子结构的天然多糖类生物大分子,其具有安全无毒、生物可降解性、成膜性好、生物相容性好、抑菌性等优点。过硫酸铵作为反应引发剂。水凝胶是具有高吸水性(含水率可达90%以上)的天然或合成聚合物网络。且水凝胶中含有大量羧基,羧基能与水形成氢键,使其具有良好的亲水性。
介入导管表面改性是抑制凝血反应的有效方法之一。表面改性以丙烯酸(AA)与丙烯酰胺(AM),通过紫外光接枝技术,使其接枝聚合在聚氨酯材料表面以改善材料表面的亲水性和抗菌性。丙烯酸与丙烯酰胺作为水凝胶原料,聚丙烯酸水凝胶作为吸附剂,对金属离子具有吸附作用。丙烯酰胺中的酰胺键(N—H)经次氯酸钠作用后可得到具有氯胺结构(N—Cl)的化合物,N—Cl键在水分子作用下缓解分解,释放出具有氧化作用的正价氯离子,正价氯离子可与微生物中的某些活性官能团发生反应从而将其杀死,且水凝胶中含有大量羧基,羧基能与水形成氢键,导致其具有良好的亲水性。壳聚糖(CS)生物方面具有良好的生物相容性,特殊的生物活性(止血,促进伤口愈合,防止组织粘连等),还具有天然的抗菌性能。本发明的方法不但提高导管的润滑性,同时还能改善导管的血液相容性和抗菌性,使介入导管更具可操作性性,减少对血管、血细胞等组织的损伤,避免表面坚硬的介入导管在血管内移动时机械剪切引起的凝血。表面改性的另一个目的是提高介入导管的抗菌粘附能力,预防介入治疗引起的败血症或静脉炎等并发症。
附图说明
图1是实施例和对比例的接枝率测试结果;
图2是水凝胶的合成录像图;
图3为聚氨酯导管血小板粘附实验扫描电镜图;
图4为实施例5的导管血小板粘附实验扫描电镜图;
图5为对比例5的导管血小板粘附实验扫描电镜图。
具体实施方式
下面结合具体的实施例对本发明作进一步说明:
实施例1
S1:将一定量的医用聚氨酯颗粒压制成导管,超声清洗10min,然后放在电热恒温鼓风干燥箱中干燥24h备用;
S2:将醋酸配制成2%醋酸水溶液,随后将丙烯酸与丙烯酰胺按相同的物质的量加入适量的醋酸水溶液配成混合液。
S3:向混合液中加入壳聚糖(CS)与过硫酸铵反应合成预聚物。
S4:向预聚物中加入(单体总质量1%)2,5-二甲基-2,5-二(叔丁基过氧化)己烷(DHBP),并在紫外灯照射下,制备出高分子水凝胶,水凝胶的合成路线图如图2所示。
S5:把称过重的聚氨酯(PU)导管(m1)浸入到水凝胶溶液中;
S6:当紫外光照射器温度升到60℃,通入氮气8min后把装有水凝胶溶液的培养皿转移到其中,用高压汞灯照射;
S7:随后导管被移出紫外光照射器,并用乙醇超声清洗7h。然后在水中清洗24h,随后放入60℃电热恒温鼓风干燥箱中干燥,直至重量不再发生变化,得到表面改性后的导管。
实施例2
S1:将一定量的医用聚氨酯颗粒压制成导管,超声清洗15min,然后放在电热恒温鼓风干燥箱中干燥24h备用;
S2:将醋酸配制成2%醋酸水溶液,随后将丙烯酸与丙烯酰胺按相同的物质的量加入适量的醋酸水溶液配成混合液。
S3:向混合液中加入壳聚糖(CS)与过硫酸铵反应合成预聚物。
S4:向预聚物中加入(单体总质量1.2%)2,5-二甲基-2,5-二(叔丁基过氧化)己烷(DHBP),并在紫外灯照射下,制备出高分子水凝胶。
S5:把称过重的聚氨酯(PU)导管(ml)浸入到水凝胶溶液中;
S6:当紫外光照射器温度升到70℃,通入氮气10min后把装有水凝胶溶液的培养皿转移到其中,用高压汞灯照射;
S7:随后导管被移出紫外光照射器,并用乙醇超声清洗8h。然后在水中清洗24h,随后放入70℃电热恒温鼓风干燥箱中干燥,直至重量不再发生变化,得到表面改性后的导管。
实施例3
S1:将一定量的医用聚氨酯颗粒压制成导管,超声清洗10min,然后放在电热恒温鼓风干燥箱中干燥24h备用;
S2:将醋酸配制成2%醋酸水溶液,随后将丙烯酸与丙烯酰胺按相同的物质的量加入适量的醋酸水溶液配成混合液。
S3:向混合液中加入壳聚糖(CS)与过硫酸铵反应合成预聚物。
S4:向预聚物总加入(单体总质量1.4%)2,5-二甲基-2,5-二(叔丁基过氧化)己烷(DHBP),并在紫外灯照射下,制备出高分子水凝胶。
S5:把称过重的聚氨酯(PU)导管(ml)浸入到水凝胶溶液中;
S6:当紫外光照射器温度升到60℃,通入氮气8min后把装有水凝胶溶液的培养皿转移到其中,用高压汞灯照射;
S7:随后导管被移出紫外光照射器,并用乙醇超声清洗7h。然后在水中清洗24h,随后放入60℃电热恒温鼓风干燥箱中干燥,直至重量不再发生变化,得到表面改性后的导管。
实施例4
S1:将一定量的医用聚氨酯颗粒压制成导管,超声清洗15min,然后放在电热恒温鼓风干燥箱中干燥24h备用;
S2:将醋酸配制成2%醋酸水溶液,随后将丙烯酸与丙烯酰胺按相同的物质的量加入适量的醋酸水溶液配成混合液。
S3:向混合液中加入壳聚糖(CS)与过硫酸铵反应合成预聚物。
S4:向预聚物中加入(单体总质量1.6%)2,5-二甲基-2,5-二(叔丁基过氧化)己烷(DHBP),并在紫外灯照射下,制备出高分子水凝胶。
S5:把称过重的聚氨酯(PU)导管(ml)浸入到水凝胶溶液中;
S6:当紫外光照射器温度升到70℃,通入氮气10min后把装有水凝胶溶液的培养皿转移到其中,用高压汞灯照射;
S7:随后导管被移出紫外光照射器,并用乙醇超声清洗8h。然后在水中清洗24h,随后放入70℃电热恒温鼓风干燥箱中干燥,直至重量不再发生变化,得到表面改性后的导管。
实施例5
S1:将一定量的医用聚氨酯颗粒压制成导管,超声清洗10min,然后放在电热恒温鼓风干燥箱中干燥24h备用;
S2:将醋酸配制成2%醋酸水溶液,随后将丙烯酸与丙烯酰胺按相同的物质的量加入适量的醋酸水溶液配成混合液。
S3:向混合液中加入壳聚糖(CS)与过硫酸铵反应合成预聚物。
S4:向预聚物中加入(单体总质量1.8%)2,5-二甲基-2,5-二(叔丁基过氧化)己烷(DHBP),并在紫外灯照射下,制备出高分子水凝胶。
S5:把称过重的聚氨酯(PU)导管(ml)浸入到水凝胶溶液中;
S6:当紫外光照射器温度升到60℃,通入氮气8min后把装有水凝胶溶液的培养皿转移到其中,用高压汞灯照射;
S7:随后导管被移出紫外光照射器,并用乙醇超声清洗7h。然后在水中清洗24h,随后放入60℃电热恒温鼓风干燥箱中干燥,直至重量不再发生变化,得到表面改性后的导管。
对比例1
S1:将一定量的医用聚氨酯颗粒压制成导管,超声清洗10min,然后放在电热恒温鼓风干燥箱中干燥24h备用;
S2:将醋酸配制成2%醋酸水溶液,随后将丙烯酸与丙烯酰胺按相同的物质的量加入适量的醋酸水溶液配成混合液。
S3:向混合液中加入壳聚糖(CS)与过硫酸铵反应合成预聚物。
S4:向预聚物中加入(单体总质量1%)二异氰酸酯(ADI),并在紫外灯照射下,制备出高分子水凝胶。
S5:把称过重的聚氨酯(PU)导管(ml)浸入到水凝胶溶液中;
S6:当紫外光照射器温度升到60℃,通入氮气8min后把装有水凝胶溶液的培养皿转移到其中,用高压汞灯照射;
S7:随后导管被移出紫外光照射器,并用乙醇超声清洗7h。然后在水中清洗24h,随后放入60℃电热恒温鼓风干燥箱中干燥,直至重量不再发生变化,得到表面改性后的导管。
对比例2
S1:将一定量的医用聚氨酯颗粒压制成导管,超声清洗15min,然后放在电热恒温鼓风干燥箱中干燥24h备用;
S2:将醋酸配制成2%醋酸水溶液,随后将丙烯酸与丙烯酰胺按相同的物质的量加入适量的醋酸水溶液配成混合液。
S3:向混合液中加入壳聚糖(CS)与过硫酸铵反应合成预聚物。
S4:向预聚物中加入(单体总质量1.2%)二异氰酸酯(ADI),并在紫外灯照射下,制备出高分子水凝胶。
S5:把称过重的聚氨酯(PU)导管(ml)浸入到水凝胶溶液中;
S6:当紫外光照射器温度升到70℃,通入氮气10min后把装有水凝胶溶液的培养皿转移到其中,用高压汞灯照射;
S7:随后导管被移出紫外光照射器,并用乙醇超声清洗8h。然后在水中清洗24h,随后放入70℃电热恒温鼓风干燥箱中干燥,直至重量不再发生变化,得到表面改性后的导管。
对比例3
S1:将一定量的医用聚氨酯颗粒压制成导管,超声清洗10min,然后放在电热恒温鼓风干燥箱中干燥24h备用;
S2:将醋酸配制成2%醋酸水溶液,随后将丙烯酸与丙烯酰胺按相同的物质的量加入适量的醋酸水溶液配成混合液。
S3:向混合液中加入壳聚糖(CS)与过硫酸铵反应合成预聚物。
S4:向预聚物中加入(单体总质量1.4%)二异氰酸酯(ADI),并在紫外灯照射下,制备出高分子水凝胶。
S5:把称过重的聚氨酯(PU)导管(ml)浸入到水凝胶溶液中;
S6:当紫外光照射器温度升到60℃,通入氮气8min后把装有水凝胶溶液的培养皿转移到其中,用高压汞灯照射;
S7:随后导管被移出紫外光照射器,并用乙醇超声清洗7h。然后在水中清洗24h,随后放入60℃电热恒温鼓风干燥箱中干燥,直至重量不再发生变化,得到表面改性后的导管。
对比例4
S1:将一定量的医用聚氨酯颗粒压制成导管,超声清洗15min,然后放在电热恒温鼓风干燥箱中干燥24h备用;
S2:将醋酸配制成2%醋酸水溶液,随后将丙烯酸与丙烯酰胺按相同的物质的量加入适量的醋酸水溶液配成混合液。
S3:向混合液中加入壳聚糖(CS)与过硫酸铵反应合成预聚物。
S4:向预聚物中加入(单体总质量1.6%)二异氰酸酯(ADI),并在紫外灯照射下,制备出高分子水凝胶。
S5:把称过重的聚氨酯(PU)导管(ml)浸入到水凝胶溶液中;
S6:当紫外光照射器温度升到70℃,通入氮气10min后把装有水凝胶溶液的培养皿转移到其中,用高压汞灯照射;
S7:随后导管被移出紫外光照射器,并用乙醇超声清洗8h。然后在水中清洗24h,随后放入70℃电热恒温鼓风干燥箱中干燥,直至重量不再发生变化,得到表面改性后的导管。
对比例5
S1:将一定量的医用聚氨酯颗粒压制成导管,超声清洗10min,然后放在电热恒温鼓风干燥箱中干燥24h备用;
S2:将醋酸配制成2%醋酸水溶液,随后将丙烯酸与丙烯酰胺按相同的物质的量加入适量的醋酸水溶液配成混合液。
S3:向混合液中加入壳聚糖(CS)与过硫酸铵反应合成预聚物。
S4:向预聚物中加入(单体总质量1.8%)二异氰酸酯(ADI),并在紫外灯照射下,制备出高分子水凝胶。
S5:把称过重的聚氨酯(PU)导管(ml)浸入到水凝胶溶液中;
S6:当紫外光照射器温度升到60℃,通入氮气8min后把装有水凝胶溶液的培养皿转移到其中,用高压汞灯照射;
S7:随后导管被移出紫外光照射器,并用乙醇超声清洗7h。然后在水中清洗24h,随后放入60℃电热恒温鼓风干燥箱中干燥,直至重量不再发生变化,得到表面改性后的导管。
对实施例1~5和对比例1~5接枝后聚氨酯表面进行相关性能测试。
接枝率测试:接枝率P(%)=(m2-m1)/m1×100%。
吸水率测试:将改性前后的导管于75℃、-0.08MPa真空干燥3h,用分析天平称重(G1),然后在蒸馏水中浸泡2h,用滤纸吸去表面的水滴,称重(G2)。吸水率(ρ)按公式ρ(%)=(G2-G1)/G1×100%计算。每组实验取5个试样,求吸水率的平均值。
表1为吸水率测试结果
表面接触角测试:将导管干燥,用德国克吕士DSA100E接触角测定仪上分别测定水和二碘甲烷在试样表面的接触角θH2O和θCH2I2,观察接触角随时间的变化。操作方法是用微量加样器取约5μL蒸馏水(二碘甲烷取约2μL)加到试样表面,测量接触角的大小,并观察接触角随时间的变化。测定温度为20℃,湿度为50%。每个试样分别取10个点,求接触角的平均值。
表2为接触角测试结果
表面摩擦系数测试:将改性前后的导管放在固定有定滑轮的水平平面的另一端,拉力机逐步增加拉力,直到质量为200g的滑块在导管表面以20mm/s的速度水平滑动,此时拉力机显示的拉力(精度为0.001N)即为摩擦力,根据摩擦因素=(摩擦力/滑块重力)的公式,计算得到滑动摩擦因素,测量三次,取其平均值。
表3为表面摩擦系数测试结果
样品 | 聚氨酯导管 | 实施例1 | 实施例2 | 实施例3 | 实施例4 | 实施例5 |
摩擦系数 | 0.478 | 0.103 | 0.067 | 0.053 | 0.042 | 0.036 |
对比例1 | 对比例2 | 对比例3 | 对比例4 | 对比例5 | ||
0.142 | 0.113 | 0.082 | 0.069 | 0.056 |
血小板粘附实验:将导管试样放入新鲜的PRP(富血小板血浆)中,于37℃水浴中孵育1h后取出,用PBS(135mmol/LNaCl;4mmol/LKCl,1.5mmol/LNaH2PO4,8mmol/LNa2H2PO4;0.02%NaN3,I=0.2,PH=7.4)轻轻洗涤样品,然后用2.0%的戊二醛固定(4℃,24h)。固定后,用50%-75%-95%-100%梯度的乙醇相继脱水各10-15分钟后,再用50%-75%-95%-100%梯度的乙酸异戊酯(第二组分为乙醇)脱水各10-15分钟;然后进行CO2临界点干燥,真空镀金,最后在扫描电镜仪上观察粘附的血小板及其形态变化。
综合上述实验结果可见:1、接枝率由图1可以很明显的看出,接枝率随着DHBP、ADI百分含量的增加而增加,且DHBP接枝情况明显要比ADI的接枝情况要好很多。2、表面涂层改性后吸水率明显增大,涂层溶液中DHBP或ADI含量越高,改性后的聚氨酯表面吸水率越大,对于相同浓度的涂层溶液,DHBP改性后的聚氨酯吸水率比ADI涂层改性后的聚氨酯吸水率高。3、接触角反映表面被湿润的难易程度,表面改性后初始接触角大于90°表明具有明显的疏水性,平衡后,在水分子的作用下,还有分子链构象改变引起表面极性的增加,则平衡接触角减小,此时表面具有良好的亲水性。4、丙烯酸与丙烯酰胺,不仅亲水性强,其产生的正价氯离子能与微生物反应将其杀死,起到灭菌作用。该方法不但提高导管的润滑性,同时还能改善材料表面的血液相容性和抗菌性,由于改性后的表面在水中形成水凝胶结构,在水中,改性表面具有较低的摩擦系数,好的润滑特性,随着涂层溶液中DHBP或ADI含量的增加,其改性后的表面在水中的摩擦系数越低,表现的润滑性越好。5、静态血小板粘附实验表明,DHBP涂层改性后的表面血小板粘附很少,且不明显激活血小板。ADI涂层改性后的表面血小板粘附也较少,但粘附量和血小板的激活程度均较DHBP涂层改性的表面粘附量的激活程度大,如图3-图5所示。此外本发明制备的介入导管材料显著提高表面润滑性和血液相融性,除此之外还提高介入导管的抗菌粘附能力,预防介入治疗引起的败血症或静脉炎等并发症。
上面结合附图对本发明的实施例进行了描述,在不冲突的情况下,本发明中的实施例及实施例中的特征可以相互组合。本发明并不局限于上述的具体实施方式,上述的具体实施方式仅仅是示意性的,而不是局限性的,本领域的普通技术人员在本发明的启示下,在不脱离本发明宗旨和权利要求所保护的范围情况下,还可做出很多形式,这些均属于本发明的保护范围之内。
Claims (6)
1.一种介入导管表面改性方法,其特征在于,包括以下步骤:
S1:利用聚氨酯颗粒制备导管,导管清洗后干燥;
S2:将丙烯酸与丙烯酰胺加入醋酸水溶液配成混合液;
S3:向混合液中加入壳聚糖与过硫酸铵反应合成预聚物;
S4:向预聚物中加入2,5-二甲基-2,5-二(叔丁基过氧化)己烷,并在紫外灯照射下,制备出高分子水凝胶;
S5:把导管浸入到水凝胶溶液中;
S6:当紫外光照射器温度升到60-70℃,通入氮气后把S5中的水凝胶溶液转移到紫外光照射器,用紫外光照射;照射时间优选为60min;
S7:取出导管后清洗干燥。
2.根据权利要求1所述的一种介入导管表面改性方法,其特征在于,所述步骤S2中,丙烯酸与丙烯酰胺的物质的量相同。
3.根据权利要求1所述的一种介入导管表面改性方法,其特征在于,所述醋酸水溶液为2%醋酸水溶液。
4.根据权利要求1所述的一种介入导管表面改性方法,其特征在于,所述步骤S4中,2,5-二甲基-2,5-二(叔丁基过氧化)己烷占预聚物质量的1%-1.8%。
5.根据权利要求1所述的一种介入导管表面改性方法,其特征在于,所述步骤S6中,氮气的通气时间为8-10min;紫外光照射60min,导管与紫外灯的距离为18-20cm。
6.根据权利要求1所述的一种介入导管表面改性方法,其特征在于,所述步骤S7中,用乙醇超声清洗7-8h,然后在水中清洗24h,随后放入60-70℃干燥箱中干燥,直至重量不再发生变化。
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