CN104644295B - 一种可吸收管腔支架及其制备方法 - Google Patents

一种可吸收管腔支架及其制备方法 Download PDF

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CN104644295B
CN104644295B CN201410815199.3A CN201410815199A CN104644295B CN 104644295 B CN104644295 B CN 104644295B CN 201410815199 A CN201410815199 A CN 201410815199A CN 104644295 B CN104644295 B CN 104644295B
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hole
shape pole
rack body
wave crest
shape
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CN104644295A (zh
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王国辉
徐波
吴永健
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Shanghai Baixin'an Biotechnology Co ltd
Fuwai Hospital of CAMS and PUMC
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Shanghai Baixinan Biotechnology Co ltd
Fuwai Hospital of CAMS and PUMC
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Priority to US14/960,860 priority patent/US10779974B2/en
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  • Health & Medical Sciences (AREA)
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  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Transplantation (AREA)
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Abstract

本发明提供一种可吸收管腔支架及其制备方法，所述可吸收管腔支架包括支架本体、制备在所述支架本体上的多个通孔、以及所述通孔内填满有生物可吸收聚合物材料。在支架植入血管内时，通过通孔内的材料与支架本体材料的复合，减少支架在压握和撑开过程中的损伤，提高支架的径向支撑力持续时间，保证支架植入后的其机械性能。

Description

一种可吸收管腔支架及其制备方法
技术领域
本发明涉及医疗器械领域，特别涉及一种可吸收管腔支架及其制备方法。
背景技术
自从1976年德国医生安德里亚〃格隆茨戈首次提出支架的设想、到20世纪90年代冠脉支架广泛应用临床以来，已经出现了第三代可吸收药物洗脱支架。但目前以不锈钢和钴铬合金为基础的药物洗脱支架(DES)仍有一定比例的病患在支架植入后出现亚急性血栓形成和再狭窄的问题，而且这类金属支架是永久留存在体内的。于是，生物可吸收支架(BVS)开始成为关注的焦点和热点。
可吸收支架理论上有多个可能的好处：支架被吸收后可恢复血管正常收缩性，阻止血管再狭窄的发生；重建普通支架置入后消失的血管动力；可在同一病变处进行多次介入干预；对患先天性疾病的儿童可使用，不需要频繁的再干预。
药物洗脱可吸收支架是未来发展方向，此研究以及其他相关试验代表了心血管研究的前沿，但目前值得关注和需要进一步研究的问题是可吸收支架的径向支撑力持续时间。对径向支撑力持续时间的影响有很大一部分原因来源于支架在植入前，是否存在因为材料或者工艺带来的损伤，而现有的高分子聚合物支架由于经历压握以及撑开这两个必要过程，出现应力集中区域损伤，带来的植入后对机械性能的影响。对此，为减小聚合物材料支架植入时带来的损伤，日本的Igaki-Tamai聚乳酸支架提出在球囊内充盈高温的造影液，来减小支架撑开过程的损伤。另有其他改进方法通过外部磁场对支架进行体内加热，使得支架在撑开过程中减小损伤。但是这些改进方法都存在支架需要在植入血管后进行加热的步骤，因支架与血管壁处于接触状态，对支架体内加热很可能导致动脉壁的受损以及坏死，随之而来的并发症是平滑肌细胞增殖，因而导致支架内再狭窄。
发明内容
本发明要解决的技术问题是提供一种可吸收管腔支架及其制备方法，在支架植入血管内时，通过通孔内的材料与支架本体材料的复合，减少支架在压握和撑开过程中的损伤。
为解决上述技术问题，本发明的实施例提供一种可吸收管腔支架，包括支架本体、制备在所述支架本体上的多个通孔、以及所述通孔内填满有生物可吸收聚合物材料。
其中，所述支架本体为网管状结构，包括多列波状的主体结构杆、连接于相邻主体结构杆之间的连接杆；
所述支架本体的每一列主体结构杆由多个基本结构杆首尾一体连接，且相邻列主体结构杆之间沿竖直方向呈左右对称；其中
所述基本结构杆包括：首尾一体相间连接的第一V形杆和第二V形杆，与所述第一V形杆的波峰一体连接的连接杆且，所述连接杆与相邻列的第二V形杆的波峰一体连接，以及制备在所述第一V形杆和/或第二V形杆上的多个通孔；
所述第一V形杆的波峰为m形波峰，所述第二V形杆的波峰为n形波峰。
进一步地，所述多个通孔分布于所述第一V形杆的波峰处与第二V形杆的波峰处以及，所述第一V形杆与第二V形杆一体连接形成的波谷处，或分布于所述支架本体的全部区域。
其中，所述通孔的横截面为圆形、椭圆、多边形、以及不规则形状。
其中，所述支架本体的壁厚为100～250微米，所述通孔的横截面面积大小为10～23000平方微米。
其中，所述支架本体的制备材料为与所述填充材料相同或不同的生物可吸收聚合物材料。
进一步地，所述生物可吸收聚合物材料选自聚乳酸PLA、左旋聚乳酸L-PLA、右旋聚乳酸D-PLA、消旋聚乳酸PDLLA、聚己内酯PCL、碳酸酯PTMC、聚对二氧环己酮PPDO、聚氨基酸衍生碳酸酯PDTE、聚原酸酯POE中一种以上，或者，以上材料中的全部或部分材料依据预定的性能配比得到的共聚物或共混物，分子量为3万～40万。
优选地，所述支架本体的制备材料为分子量30万的PLA，所述填充材料为分子量5万～10万的PCL。
为了解决上述问题，本发明实施例还提出了一种可吸收管腔支架的制备方法，包括：
步骤1，将生物可吸收聚合物材料通过挤出得到管材，然后用吹塑法进行管材热膨胀，得到薄壁管材，采用激光雕刻技术进行将所述薄壁管材雕刻成支架；
步骤2，在支架本体压握和/或撑开时的应力集中部位或者支架本体的所有部位上采用激光雕刻技术制备多个通孔；
步骤3，在所述通孔内填满生物可吸收聚合物材料。
优选地，所述步骤3包括：
步骤3a，将生物可吸收聚合物材料制备成球状填充物，将所述球状填充物镶嵌放置在所述通孔内；
步骤3b，在所述支架的内外壁上嵌套模具管材，然后放置在60℃～80℃的真空烘箱内进行加热处理30分钟～2小时，直至支架材料与填充材料紧密结合。
优选地，所述步骤3包括：
步骤3a’，将生物可吸收材料投放至溶解液中溶解，得到溶解后的溶液，然后将溶液注射于所述通孔内；
步骤3b’，在所述支架的内外壁上嵌套模具管材，然后放置在30℃～40℃的真空烘箱内进行烘干处理30分钟～12小时；
步骤3c”，重复执行上述步骤3a’-3b’，直至填充材料充满所述通孔。
优选地，所述步骤3包括：
步骤3a”，将生物可吸收聚合物粒料放置在60℃～70℃加热注射器内，直至材料处于熔融状态，将所述熔融状态下的材料灌注在所述通孔内；
步骤3b”，在所述支架的内外壁上嵌套模具管材，然后放置在60℃～80℃的真空烘箱内进行加热处理30分钟～2小时，直至支架材料与填充材料紧密结合。
进一步地，所述步骤2中，进一步通过化学腐蚀或物理打孔方式，制备所述通孔。
本发明的上述技术方案至少包括以下有益效果：
上述方案中，通过在支架本体压握和/或撑开时的应力集中区域上制备通孔，即在第一V形杆的波峰处与第二V形杆的波峰处以及第一V形杆与第二V形杆一体连接形成的波谷处制备多个通孔，并采用生物可吸收合物材料聚己内酯(PCL)材料填满通孔，利用真空烘箱加热烘干使填充材料与支架材料紧密结合。在整个支架植入过程中，不存在对支架体内加热的过程，只是通过通孔内的材料与支架主体材料的复合，减小支架在压握以及撑开过程中的损伤，提高支架的径向支撑力持续时间，保证支架植入后的其机械性能。
附图说明
图1为本发明实施例可吸收管腔支架展开面示意图；
图2为发明实施例的通孔的几种布置关系示意图；
图3为本发明实施例中模具管材示意图。
[主要附图标记说明]
10-支架本体、20-主体结构杆、21-基本结构杆、22-第一V形杆、23-第二V形杆、24-通孔、30-连接杆
具体实施方式
为使本发明要解决的技术问题、技术方案和优点更加清楚，下面将结合实施例对本发明的优选方案进行描述。这些描述只是举例说明本发明的特征和优点，而非限制本发明的保护范围。
针对现有技术中高分子聚合物支架由于经历压握以及撑开这两个必要过程，出现应力集中区域损伤而带来的植入后对机械性能的影响，以及为减少损伤必须在体内加热的弊端，本发明提出了一种可吸收管腔支架及其制备方法，通过在支架本体压握和/或撑开时的应力集中区域上制备通孔，即在第一V形杆的波峰处与第二V形杆的波峰处以及第一V形杆与第二V形杆一体连接形成的波谷处制备多个通孔，并采用生物可吸收合物材料聚己内酯(PCL)材料填满通孔，利用真空烘箱加热烘干使填充材料与支架材料紧密结合。因此在支架植入过程中，无须对其进行体内加热，仅通过通孔内的材料与支架主体材料的复合，减小支架在压握以及撑开过程中的损伤，有效提高了支架的径向支撑力持续时间，保证了支架植入后对其机械性能。
本发明的实施例中，支架本体10的制备材料与填充材料选用分子量3万～40万之间，包括但不限于聚乳酸(PLA)、左旋聚乳酸(L-PLA)、右旋聚乳酸(D-PLA)、消旋聚乳酸(PDLLA)、聚己内酯(PCL)、碳酸酯(PTMC)、聚对二氧环己酮(PPDO)、聚氨基酸衍生碳酸酯(PDTE)、聚原酸酯(POE)等中一种以上的材料，或者，以上材料中的全部或部分材料依据预定的性能配比得到的共聚物或共混物。填充材料优选分子量5万～10万的生物可吸收聚合物材料。其中，支架本体10与填充材料可以选用相同或者不同的生物可吸收聚合物材料。本发明的实施例的可吸收管腔支架使用的材料都是生物可吸收聚合物材料，具备良好的生物相容性，在支架植入体内3个月后逐渐发生降解，最终降解为人体可吸收无毒产物如水和二氧化碳，可使支架消失后的血管恢复自然。
本发明的实施例一，如图1所示为本发明实施例可吸收管腔支架展开面示意图，选用分子量30万的PLA原料挤出管材，然后用吹塑法进行管材热膨胀，得到壁厚为100μm的薄壁聚乳酸管材，通过激光雕刻技术加工成支架本体10，采用物理除渣，得到支架本体10，然后通过激光雕刻技术在支架本体10制备出横截面面积大小为10～23000平方微米，优选为横截面面积大小为5000～10000平方微米的通孔24。
具体的，所述支架本体10为网管状结构，包括多列波状的主体结构杆20、连接于相邻主体结构杆20之间的连接杆30；所述支架本体10的每一列主体结构杆20由多个基本结构杆21首尾一体连接，且相邻列主体结构杆20之间沿竖直方向呈左右对称；其中所述基本结构杆21包括：首尾一体相间连接的第一V形杆22和第二V形杆23，与所述第一V形杆22的波峰一体连接的连接杆30且，所述连接杆30与相邻列的第二V形杆23的波峰一体连接，以及制备在所述第一V形杆22和/或第二V形杆23上的多个通孔24；所述第一V形杆22的波峰为m形波峰，所述第二V形杆23的波峰为n形波峰。所述多个通孔24制备在可吸收管腔支架压握和/或撑开时的应力集中区域，即制备在所述第一V形杆22的波峰处与第二V形杆23的波峰处以及，所述第一V形杆22与第二V形杆23一体连接形成的波谷处。显然地，所述多个通孔24也可以被制备在支架本体10的全部区域。
其中，如图2为发明实施例的通孔的几种布置关系示意图，由上往下，所述通孔24的横截面分别为圆形、多边形、以及不规则形状。需要说明的是，以上示例的圆形、多边形、不规则图形，仅为本发明的较佳实施例，不用于限制本申请的保护范围，通孔24的横截面还可以椭圆、三角形、心形、星形等等。
将分子量为10万的PCL材料制备成直径为50～200μm的球状材料，并放置在支架本体10上的通孔24内；如图3所示为本发明实施例中模具管材示意图，将支架内表面嵌套在管材外径比支架内径小0.1mm，支架外表面嵌套在管材内径比支架外径大0.1mm的304不锈钢模具管材；然后将支架放置于60～80℃，优选为65℃的氦气保护氛围的真空烘箱内进行加热，加热时间为30分钟～2小时，优选为40分钟，使支架材料与填充材料紧密结合。在支架植入体内3个月后逐渐发生降解，最终降解为人体可吸收无毒产物如水和二氧化碳，可使支架消失后的血管恢复自然。
本发明的实施例二，如图1-3所示，选用分子量30万的碳酸酯(PTMC)原料挤出管材，然后用吹塑法进行管材热膨胀，得到壁厚为250μm的薄壁管材，通过激光雕刻技术加工成支架本体10，采用物理除渣，得到支架本体10；通过物理打孔技术在支架本体10上制备出横截面面积大小为5000～10000平方微米的不规则形状的通孔24；将分子量5万的PCL材料按1:5～1:100的比例溶解于溶解液，得到溶解后的溶液，将溶液注射于通孔24内；然后放置于30℃～40℃，优选为37℃的氮气保护氛围的真空烘箱内烘干，往复多次，直至PCL填充满通孔24。其中，支架在真空烘箱内处理时间为30分钟～12小时，优选为8小时。本发明的上述实施例中，溶解液可以为四氢呋喃、氯仿、二氯甲烷或丙酮中的一种或几种溶液。在支架植入体内3个月后逐渐发生降解，最终降解为人体可吸收无毒产物如水和二氧化碳，可使支架消失后的血管恢复自然。
本发明的实施例三，如图1-3所示，选用分子量30万的聚原酸酯(POE)挤出管材，然后用吹塑法进行管材热膨胀，得到壁厚为250μm的薄壁管材，通过激光雕刻技术加工成支架本体10，采用物理除渣，得到支架本体10；通过化学腐蚀技术在支架本体10上制备出横截面面积大小为10000平方微米的多边形通孔24；将分子量10万的PCL粒料放置在60℃～70℃，优选为65℃的加热注射器内，使其处于熔融状态，然后将熔融状态的PCL材料挤入通孔内；如图3所示，将支架内表面嵌套在管材外径比支架内径小0.1mm，支架外表面嵌套在管材内径比支架外径大0.1mm的304不锈钢模具管材；然后将支架放置于60～80℃，优选为65℃的真空氛围下的真空烘箱内进行加热，加热时间为30分钟～2小时，优选为40分钟，使支架材料与填充材料紧密结合。在支架植入体内3个月后逐渐发生降解，最终降解为人体可吸收无毒产物如水和二氧化碳，可使支架消失后的血管恢复自然。
本发明的可吸收管腔支架的至少包括如下优点：在整个支架植入过程中，不存在对支架体内加热的过程，只是通过通孔内的材料与支架主体材料的复合，减小支架在压握以及撑开过程中的损伤，提高支架的径向支撑力持续时间，保证支架植入后的其机械性能。
以上所述是本发明的优选实施方式，应当指出，对于本技术领域的普通技术人员来说，在不脱离本发明所述原理的前提下，还可以作出若干改进和润饰，这些改进和润饰也应视为本发明的保护范围。

Claims (6)

1.一种可吸收管腔支架，其特征在于，包括支架本体、制备在所述支架本体上的多个通孔、以及所述通孔内填满有生物可吸收聚合物材料；
其中，所述支架本体的制备材料为与所述通孔内的填充材料相同或不同的生物可吸收聚合物材料，且所述生物可吸收聚合物材料选自聚乳酸PLA、左旋聚乳酸L-PLA、右旋聚乳酸D-PLA、消旋聚乳酸PDLLA、聚己内酯PCL、碳酸酯PTMC、聚对二氧环己酮PPDO、聚氨基酸衍生碳酸酯PDTE、聚原酸酯POE中一种以上，或者，以上材料中的全部或部分材料依据预定的性能配比得到的共聚物或共混物，分子量为3万～40万；
所述支架本体为网管状结构，包括多列波状的主体结构杆、连接于相邻主体结构杆之间的连接杆；
所述支架本体的每一列主体结构杆由多个基本结构杆首尾一体连接，且相邻列主体结构杆之间沿竖直方向呈左右对称；其中
所述基本结构杆包括：首尾一体相间连接的第一V形杆和第二V形杆，与所述第一V形杆的波峰一体连接的连接杆且，所述连接杆与相邻列的第二V形杆的波峰一体连接，以及制备在所述第一V形杆和/或第二V形杆上的多个通孔；
所述第一V形杆的波峰为m形波峰，所述第二V形杆的波峰为n形波峰；
所述多个通孔分布于所述第一V形杆的波峰处与第二V形杆的波峰处以及，所述第一V形杆与第二V形杆一体连接形成的波谷处，或分布于所述支架本体的全部区域；
其中，所述通孔内通过如下方式填满生物可吸收聚合物材料：
步骤3a，将生物可吸收聚合物材料制备成球状填充物，将所述球状填充物镶嵌放置在所述通孔内；
步骤3b，在所述支架的内外壁上嵌套模具管材，然后放置在60℃～80℃的真空烘箱内进行加热处理30分钟～2小时，直至支架材料与填充材料紧密结合；
或者，步骤3a’，将生物可吸收材料投放至溶解液中溶解，得到溶解后的溶液，然后将溶液注射于所述通孔内；
步骤3b’，在所述支架的内外壁上嵌套模具管材，然后放置在30℃～40℃的真空烘箱内进行烘干处理30分钟～12小时；
步骤3c”，重复执行上述步骤3a’-3b’，直至填充材料充满所述通孔；
或者，步骤3a”，将生物可吸收聚合物粒料放置在60℃～70℃的加热注射器内，直至材料处于熔融状态，将所述熔融状态下的材料灌注在所述通孔内；
步骤3b”，在所述支架的内外壁上嵌套模具管材，然后放置在60℃～80℃的真空烘箱内进行加热处理30分钟～2小时，直至支架材料与填充材料紧密结合。
2.根据权利要求1所述的可吸收管腔支架，其特征在于，所述通孔的横截面为圆形、椭圆、多边形、以及不规则形状。
3.根据权利要求1所述的可吸收管腔支架，其特征在于，所述支架本体的壁厚为100～250微米，所述通孔的横截面面积大小为10～23000平方微米。
4.根据权利要求1所述的可吸收管腔支架，其特征在于，所述支架本体的制备材料为分子量30万的PLA，所述填充材料为分子量5万～10万的PCL。
5.一种可吸收管腔支架的制备方法，其特征在于，包括：
步骤1，将生物可吸收聚合物材料通过挤出得到管材，然后用吹塑法进行管材热膨胀，得到薄壁管材，采用激光雕刻技术进行将所述薄壁管材雕刻成支架；
步骤2，在支架本体压握和/或撑开时的应力集中部位或者支架本体的所有部位上采用激光雕刻技术制备多个通孔；
步骤3，在所述通孔内填满生物可吸收聚合物材料；
其中，所述支架本体的制备材料为与所述通孔内的填充材料相同或不同的生物可吸收聚合物材料，且所述生物可吸收聚合物材料选自聚乳酸PLA、左旋聚乳酸L-PLA、右旋聚乳酸D-PLA、消旋聚乳酸PDLLA、聚己内酯PCL、碳酸酯PTMC、聚对二氧环己酮PPDO、聚氨基酸衍生碳酸酯PDTE、聚原酸酯POE中一种以上，或者，以上材料中的全部或部分材料依据预定的性能配比得到的共聚物或共混物，分子量为3万～40万；
所述支架本体为网管状结构，包括多列波状的主体结构杆、连接于相邻主体结构杆之间的连接杆；
所述支架本体的每一列主体结构杆由多个基本结构杆首尾一体连接，且相邻列主体结构杆之间沿竖直方向呈左右对称；其中
所述基本结构杆包括：首尾一体相间连接的第一V形杆和第二V形杆，与所述第一V形杆的波峰一体连接的连接杆且，所述连接杆与相邻列的第二V形杆的波峰一体连接，以及制备在所述第一V形杆和/或第二V形杆上的多个通孔；
所述第一V形杆的波峰为m形波峰，所述第二V形杆的波峰为n形波峰；
所述多个通孔分布于所述第一V形杆的波峰处与第二V形杆的波峰处以及，所述第一V形杆与第二V形杆一体连接形成的波谷处，或分布于所述支架本体的全部区域；
其中，所述步骤3包括：
步骤3a，将生物可吸收聚合物材料制备成球状填充物，将所述球状填充物镶嵌放置在所述通孔内；
步骤3b，在所述支架的内外壁上嵌套模具管材，然后放置在60℃～80℃的真空烘箱内进行加热处理30分钟～2小时，直至支架材料与填充材料紧密结合；
或者，步骤3a’，将生物可吸收材料投放至溶解液中溶解，得到溶解后的溶液，然后将溶液注射于所述通孔内；
步骤3b’，在所述支架的内外壁上嵌套模具管材，然后放置在30℃～40℃的真空烘箱内进行烘干处理30分钟～12小时；
步骤3c”，重复执行上述步骤3a’-3b’，直至填充材料充满所述通孔；
或者，步骤3a”，将生物可吸收聚合物粒料放置在60℃～70℃的加热注射器内，直至材料处于熔融状态，将所述熔融状态下的材料灌注在所述通孔内；
步骤3b”，在所述支架的内外壁上嵌套模具管材，然后放置在60℃～80℃的真空烘箱内进行加热处理30分钟～2小时，直至支架材料与填充材料紧密结合。
6.根据权利要求5所述的可吸收管腔支架的制备方法，其特征在于，所述步骤2中，进一步通过化学腐蚀或物理打孔方式，制备所述通孔。
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