CN111110413A - 一种具有微孔阵列的颅内可降解生物支架及其制备方法 - Google Patents
一种具有微孔阵列的颅内可降解生物支架及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种具有微孔阵列的颅内生物可降解支架及其制备方法，该生物可降解支架上排布有紧密的微孔，采用激光束在非金属支架上精准制造最密排分布的微孔，在血管支架表面和微孔上载有多层梯度药物，可以增大储药量。血管支架送入颅内的血管后，能够增大接触面积，提高药物释放数量。由于血管支架质量小，在人体血管内降解速率快，能够加快病变部位的恢复。本发明提出的颅内生物可降解支架及其制备方法全过程自动化，具有操作简便性和较高的成品率。
Description
技术领域：
本发明属于医疗领域，具体地说，涉及一种具有微孔阵列的颅内可降解生物支架及其制备方法。
背景技术：
目前作为治疗包括脑梗塞的主要医疗器械，药物涂层支架本体一直采用惰性金属材料，多以316L医用不锈钢，钴铬合金为主，此类金属支架作为异源性物质植入血管将一直存留于人体，当发生再狭窄时使治疗变得更加棘手。而且，目前作为药物载体的高分子也是不可降解的材料，在药物释放以后也将永远存留于人体，对一些病人会引起致命的亚急性栓塞或后期血栓。
因此，研究采用一种可生物降解材料作为支架，使其具有金属支架的各种力学性能，且不改变现在采用的输送方法，成为微创介入医疗器械领域目前的另一个研究热点领域。生物可降解支架在植入血管病变位置后，可以实现金属支架的支撑功能，在其所载治疗药物释放完全后，其本体可在一段时间内逐步降解为可以被人体所吸收的无毒副作用的物质，直至完全降解。
目前在生物可降解支架方面，美国雅培公司的BVS支架和美国Elixir Medical公司的DESolve支架已进入临床试验阶段，该类血管支架在机械强度、体积、降解性能及所载药物的释放速度等方面还不能完全适应临床的需要。同时，支架质量较大，在血管内负荷较大。支架表面积有限，载药量不足也是当前血管支架遇见的问题。此外，现有血管支架在加工面比较粗糙，制造精度不高，成品率也很低，在很大程度上制约了其推广和应用。因此需要解决上述问题，提高颅内可降解生物支架的作用效果。
发明内容：
为了解决上述问题，本发明提出了一种具有微孔阵列的颅内生物可降解支架及其制备方法。该制备方法所制备的颅内血管支架能够解决现有的相关支架质量大、血管内负荷较大、载药量不足、制造精度不高等问题，而且强度适中、加工塑性较好，机械强度和体积能够达到临床的要求，并可通过对该支架的表面处理，使其作为药物的载体，能靶定位缓释药物，同时该制备方法成本相对较低，制造精度高，成形效率高。
为达到上述目的，本发明的技术方案如下：
一种具有微孔阵列的颅内生物可降解支架，包括支架本体，所述支架本体包括环状结构a、波杆、环状结构b，所述环状结构a与环状结构b平行设置，所述波杆在中间连通环状结构a与环状结构b，在支架本体上开有最密排阵列的微孔，微孔的形状为圆形、三角形、六边形或十二边形，所述环状结构a与环状结构b为中空的波浪形管道，在支架本体的表面和微孔内涂敷药物层。
一种具有微孔阵列的颅内生物可降解支架的制备方法，具体包括以下步骤：
（1）原始管材制备步骤，其中利用可降解材料制备具有预定内、外径的原始管材；
（2）膨胀步骤，其中将原始管材放入模具中，对原始管材进行加热和加压，使原始管材膨胀以使其外径尺寸达到模具的内径尺寸；
（3）支架主体制备步骤，其中使膨胀后的管材冷却，并制备成最终的可降解支架；
（4）血管支架镂空结构加工：支架上的镂空结构可以采用激光加工，将管材在膨胀成型以后选用飞秒或皮秒激光器对管材进行切割，其中，激光波长应不大于400 nm，功率范围0.6 mW-6 W，脉冲间隔60-6000 fs；
（5）血管支架打孔步骤：利用微孔制造遮蔽板在可降解支架上打孔，激光照射在微孔制造遮蔽样板板上，在支架上形成相同图案的微孔，利用激光束和可降解支架的相对运动完成微孔密排阵列的加工。微孔的激光加工采用的激光波长应不大于400 nm，功率范围0.6mW-1 W，脉冲间隔60-1000 fs；
（6）涂药步骤：在激光切割和激光打孔得到成型的可降解支架后，在支架的表面和微孔内涂敷药物层，将可降解支架植入血管内适当位置之后，按照需求将表面涂敷或内部分布的药物缓慢释放到血管壁，从而抑制了血管的内膜增生，降低再狭窄的出现率。所涂药物按照梯度循环排布，药物逐层释放，并以此循环，实现往复循环治疗的目标。
一种具有微孔阵列的颅内生物可降解支架，所涂敷的药物选自抗癌药物、抗凝血剂、微生物免疫抑制剂以及其它抗再狭窄药物中的一种或多种。
所述抗癌药物选自甲氨蝶呤、嘌呤类、嘧啶类、植物碱类、埃坡霉素类、雷公藤系列化合物、抗生素（特别是放线菌素-D）、激素、抗体治癌药物中的一种或多种。优选地，所述植物碱类抗癌药物为紫杉醇。
所述抗凝血剂选自肝素、阿司匹林、水蛭素、秋水仙碱、抗血小板GP Ⅱ b/ Ⅲ a受体结抗剂中的一种或多种。
所述微生物免疫抑制剂选自环孢霉素A、他克莫司及同系物、脱精胍菌素、酶酚酸脂、雷帕霉素及其衍生物、链霉菌种类的菌株FR900520、链霉菌种类的菌株FR900523、达珠单抗、戊酰胺、康乐霉素C、司加林、灵菌红素25c、曲尼司特、多球壳菌素、环孢霉素C、布雷青霉素、麦考酚酸、布雷菲德菌素A、酮皮质类固醇中的一种或多种。
一种具有微孔阵列的颅内生物可降解支架的制备加工过程中利用99.999%以上纯度的氦气进行冷却，减少热效应。
本发明相比现有技术，具有以下有益效果：
（1）本发明提出的颅内血管支架具有防止对血管壁造成损伤、力学性能好的特点，而且具有可以载药、载药量大、药物释放方便的优点。
（2）本发明提出的颅内血管支架具有支架质量较轻，在血管内负荷较小的特点，更适用于人体颅内血管。
（3）本发明提出的颅内血管支架具有密排微孔阵列，能够极大的提高载药面积，以及血管支架和血管壁的接触面积，防止对血管壁造成损伤，提升药物的作用效果。
（4）本发明提出的颅内血管支架具有质量轻的特点，在血管内分解时所需时间较短，具有良好的降解特性，能够更适应于人体的治疗需要。
附图说明：
图1 本发明的可降解支架的展开结构
图2 多层药物涂敷示意图
图3 本发明的微孔制造遮蔽板
1、环状结构a；2、波峰；3、微孔；4、波杆；5、环状结构b；6、支架基底；7、药物1；8、药物2；9、微孔制造遮蔽样板；10、微孔缺口。
具体实施方式：
下面结合附图和具体实施例，进一步阐明本发明，应理解这些实例仅用于说明本发明而不用于限制本发明的范围，在阅读了本发明之后，本领域技术人员对本发明的各种等价形式的修改均落于本申请所附权利要求所限定的范围。
如图所示，本发明所述的一种具有微孔阵列的颅内生物可降解支架，包括支架本体，所述支架本体包括环状结构a、波杆4、环状结构b，所述环状结构a与环状结构b平行设置，所述波杆在中间连通环状结构a与环状结构b，在支架本体上开有最密排阵列的微孔3，微孔的形状为圆形、三角形、六边形或十二边形，微孔直径为5~10微米，所述环状结构a与环状结构b为中空的波浪形管道，有波峰2与波谷，在支架本体的表面和微孔3内涂敷药物层。
血管支架环状结构a和环状结构b镂空结构加工采用激光加工，将管材在膨胀成型以后选用飞秒或皮秒激光器对管材进行切割，其中，激光波长应不大于400 nm，功率范围0.6 mW-6 W,脉冲间隔60-6000 fs。
血管支架微孔3的打孔利用微孔制造遮蔽样板9在可降解支架基底6上打孔，激光照射在微孔制造遮蔽样板9上，在支架基底6上形成相同图案的微孔1，利用激光束和可降解支架的相对运动完成微孔密排阵列的加工。微孔的激光加工采用的激光波长应不大于400nm，功率范围0.6 mW-1 W, 脉冲间隔60-1000 fs。
在激光切割和激光打孔得到成型的可降解支架后，在血管支架的表面和微孔3内涂敷药物层，如图2所示。药物层根据病变特点，采用梯度药物涂覆层。例如先涂敷药物1，再涂敷药物2，循环往复完成药物涂层。将可降解支架植入血管内适当位置之后，按照需求将表面涂敷或微孔3内部分布的药物缓慢释放到血管壁，从而抑制了血管的内膜增生，降低再狭窄的出现率。所涂药物按照梯度循环排布，药物逐层释放，并以此循环，实现往复循环治疗的目标。
本发明方案所公开的技术手段不仅限于上述实施方式所公开的技术手段，还包括由以上技术特征任意组合所组成的技术方案。
Claims (9)
1.一种具有微孔阵列的颅内可降解生物支架，包括支架本体，其特征在于：所述支架本体包括环状结构a、波杆、环状结构b，所述环状结构a与环状结构b平行设置，所述波杆在中间连通环状结构a与环状结构b，整体形成闭合的环状支架，在支架本体上开有最密排阵列的微孔，微孔的形状为圆形、三角形、六边形或十二边形，所述环状结构a与环状结构b为中空的波浪形管道，在支架本体的表面和微孔内涂敷药物层。
2.根据权利要求1所述的一种具有微孔阵列的颅内可降解生物支架，其特征在于：所涂敷的药物选自抗癌药物、抗凝血剂、微生物免疫抑制剂以及其它抗再狭窄药物中的一种或多种。
3.根据权利要求2所述的一种具有微孔阵列的颅内可降解生物支架，其特征在于：所述抗癌药物选自甲氨蝶呤、嘌呤类、嘧啶类、植物碱类、埃坡霉素类、雷公藤系列化合物、抗生素、激素、抗体治癌药物中的一种或多种。
4.根据权利要求1所述的一种具有微孔阵列的颅内可降解生物支架，其特征在于：所述抗凝血剂选自肝素、阿司匹林、水蛭素、秋水仙碱、抗血小板GP Ⅱ b/ Ⅲ a 受体结抗剂中的一种或多种。
5.根据权利要求1所述的一种具有微孔阵列的颅内可降解生物支架，其特征在于：所述微生物免疫抑制剂选自环孢霉素A、他克莫司及同系物、脱精胍菌素、酶酚酸脂、雷帕霉素及其衍生物、链霉菌种类的菌株FR900520、链霉菌种类的菌株FR900523、达珠单抗、戊酰胺、康乐霉素C、司加林、灵菌红素25c、曲尼司特、多球壳菌素、环孢霉素C、布雷青霉素、麦考酚酸、布雷菲德菌素A、酮皮质类固醇中的一种或多种。
6.根据权利要求1所述的一种具有微孔阵列的颅内可降解生物支架，其特征在于：所述药物层采用梯度药物涂覆层。
7.根据权利要求1所述的一种具有微孔阵列的颅内可降解生物支架，其特征在于：所述微孔直径为5~10微米。
8.根据权利要求1所述的一种具有微孔阵列的颅内可降解生物支架的制备方法，其特征在于：具体包括以下步骤：
（1）原始管材制备：利用可降解材料制备具有预定内、外径的原始管材；
（2）膨胀步骤：将原始管材放入模具中，对原始管材进行加热和加压，使原始管材膨胀以使其外径尺寸达到模具的内径尺寸；
（3）支架主体制备步骤：使膨胀后的管材冷却，并制备成支架本体；
（4）血管支架镂空结构加工：支架上的镂空结构采用激光加工，将管材在膨胀成型以后选用飞秒或皮秒激光器对管材进行切割，其中，激光波长应不大于400 nm，功率范围0.6mW-6 W，脉冲间隔60-6000 fs；
（5）血管支架打孔步骤：利用微孔制造遮蔽板在支架本体上打孔，激光照射在微孔制造遮蔽样板板上，在支架上形成相同图案的微孔，利用激光束和支架本体的相对运动完成微孔密排阵列的加工，微孔的激光加工采用的激光波长应不大于400 nm，功率范围0.6 mW-1W，脉冲间隔60-1000 fs；
（6）涂药步骤：在激光切割和激光打孔得到成型的可降解支架后，在支架本体的表面和微孔内涂敷药物层。
9.根据权利要求8所述的一种具有微孔阵列的颅内可降解生物支架的制备方法，其特征在于：制备加工过程步骤（3）—（6）中利用99.999%以上纯度的氦气对支架本体进行冷却。
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| CN114795608A (zh) * | 2022-04-20 | 2022-07-29 | 上海交通大学 | 微织构化动脉血管支架及其制备装置和方法 |
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