脂肪族聚碳酸酯涂层支架的制备和性能研究
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摘要
经皮冠状动脉介入治疗(PCI)在三十余年时间里,历经了单纯的球囊扩张、金属裸支架(BMS)到药物洗脱支架(DES)三次飞跃。DES可以将一定负荷剂量的药物直接带到病变血管部位,使再狭窄率降低到10%以下。DES是在金属支架表面覆有一层或两层稳定聚合物涂层,以完成带药和释药的目的,聚合物和支架一样永久留存在血管中。DES的永久聚合物涂层可能是导致血管延迟愈合和(极)晚期支架内血栓的重要原因,因此发展对血管壁低毒的新型支架是当前研究热点。可降解聚合物涂层DES是研究趋势之一。
可降解聚合物作为DES的药物载体,在完成其任务后,逐渐降解为小分子,避免了永久聚合物对血管壁的长期刺激。本文实验选择表面溶蚀降解方式的脂肪族聚碳酸酯(APC)作为支架的可降解聚合物涂层材料,将其和雷帕霉素的溶液直接涂覆到316L不锈钢支架上制备DES。论文的主要内容和结果包括：
1.研究了316L不锈钢支架表面处理和DES喷涂工艺,确定了合适的工艺参数；然后讨论了手动浸涂和自动喷涂两种涂层方法对涂层性能的影响,并从理论上分析了产生不同影响的原因。
2.研究了脂肪族聚碳酸酯在PBS模拟体液中的质量丢失率和吸水率,根据实验结果优选聚碳酸亚乙酯(PEC)和聚碳酸亚丙亚乙酯(PPEC)作为支架涂层材料；然后从细胞毒性试验、溶血试验和部分凝血激活酶时间试验初步证明,PEC和PPEC具有优良的生物相容性。
3.用戊二酸锌催化合成了PPEC,并深入研究了PEC和PPEC作为冠脉支架涂层材料的可行性,实验结果证明,脂肪族聚碳酸酯载药涂层支架具有广阔的应用前景。
4.详细考察了屏蔽层、药物梯度、载体种类、载体和药物的比例以及释放介质对DES药物释放的影响,明确了涂层药物释放模式及其控制因素,优化了可降解药物载体和DES的设计。
Percutaneous coronary intervention (PCI) has experienced angioplasty balloon, bare metal stents (BMS) and drug-eluting stent (DES) for more than30years. DES can delivery drugs directly to the targeted lesion site and decreases coronary restenosis rate to less than10%. DES is prepared with a layer or two layers of durable polymer coating on the metal stent surface in order to complete the purpose of medicine and drug delivery. The polymer and BMS will permanently retain in the blood vessel. The durable polymer may lead to vascular delay healing and (very) late stent thrombosis. Therefore, the motivation behind the development of newer devices has been the attainment of optimal antirestenotic efficacy at a minimum of arterial wall toxicity. Biodegradable polymer DES is one of the research trends.
Biodegradable polymer DES offer controlled elution of active drug from the stent backbone by means of a biocompatible polymer coating, which after completion of its useful function, slowly degrades to inert organic monomers, thereby dissipating the risk associated with the long-term presence of durable polymer in the coronary vessel wall. Aliphatic polycarbonate (APC) has been shown to have good biodegradability and biocompatibility in vivo. In this paper, APC is reported as stent coating material and is directly coated on the surface of316L stainless steel stent. The paper includes the following contents:
1. The surface treatment of316L stainless steel stent and spray-coating procedure of DES are investigated, and the appropriate process parameters are gained. And then effects of preparation methods on property and drug release kinetics of sirolimus-loading DES are discussed, finally the reasons for different effects are theoretically analyzed in detail.
2. Mass loss and water intake rate of APC are studied in phosphate buffered saline (PBS). Poly(ethylene carbonate)(PEC) and poly(propylene ethylene carbonate)(PPEC) are preferably chosen as stent coating materials according to the experimental results. Then the excellent biocompatibilities of PEC and PPEC are preliminarily demonstrated by in vitro cytotoxicity test (MTT assay), hemolysis test and partial thromboplastin time test (PTT).
3. PPEC is synthesized by ethylene oxide (EO), propylene oxide (PO) and carbon dioxide (CO2) and catalyzed by glutaric zinc (ZnGA). Then in vitro feasibility studies of the utility of PEC and PPEC as coating materials for drug-eluting stent are reported. All the experimental results demonstrate that drug-loading APC coating stents have broad application prospects.
4. Factors to affect drug release of DES are researched in vitro. The factors include drug free polymer, drug gradient layer, the mass ratio of carrier and drug, different drug carriers and drug release medium. The results can optimize the design of biodegradable drug carrier and DES.
可降解聚合物作为DES的药物载体,在完成其任务后,逐渐降解为小分子,避免了永久聚合物对血管壁的长期刺激。本文实验选择表面溶蚀降解方式的脂肪族聚碳酸酯(APC)作为支架的可降解聚合物涂层材料,将其和雷帕霉素的溶液直接涂覆到316L不锈钢支架上制备DES。论文的主要内容和结果包括：
1.研究了316L不锈钢支架表面处理和DES喷涂工艺,确定了合适的工艺参数；然后讨论了手动浸涂和自动喷涂两种涂层方法对涂层性能的影响,并从理论上分析了产生不同影响的原因。
2.研究了脂肪族聚碳酸酯在PBS模拟体液中的质量丢失率和吸水率,根据实验结果优选聚碳酸亚乙酯(PEC)和聚碳酸亚丙亚乙酯(PPEC)作为支架涂层材料；然后从细胞毒性试验、溶血试验和部分凝血激活酶时间试验初步证明,PEC和PPEC具有优良的生物相容性。
3.用戊二酸锌催化合成了PPEC,并深入研究了PEC和PPEC作为冠脉支架涂层材料的可行性,实验结果证明,脂肪族聚碳酸酯载药涂层支架具有广阔的应用前景。
4.详细考察了屏蔽层、药物梯度、载体种类、载体和药物的比例以及释放介质对DES药物释放的影响,明确了涂层药物释放模式及其控制因素,优化了可降解药物载体和DES的设计。
Percutaneous coronary intervention (PCI) has experienced angioplasty balloon, bare metal stents (BMS) and drug-eluting stent (DES) for more than30years. DES can delivery drugs directly to the targeted lesion site and decreases coronary restenosis rate to less than10%. DES is prepared with a layer or two layers of durable polymer coating on the metal stent surface in order to complete the purpose of medicine and drug delivery. The polymer and BMS will permanently retain in the blood vessel. The durable polymer may lead to vascular delay healing and (very) late stent thrombosis. Therefore, the motivation behind the development of newer devices has been the attainment of optimal antirestenotic efficacy at a minimum of arterial wall toxicity. Biodegradable polymer DES is one of the research trends.
Biodegradable polymer DES offer controlled elution of active drug from the stent backbone by means of a biocompatible polymer coating, which after completion of its useful function, slowly degrades to inert organic monomers, thereby dissipating the risk associated with the long-term presence of durable polymer in the coronary vessel wall. Aliphatic polycarbonate (APC) has been shown to have good biodegradability and biocompatibility in vivo. In this paper, APC is reported as stent coating material and is directly coated on the surface of316L stainless steel stent. The paper includes the following contents:
1. The surface treatment of316L stainless steel stent and spray-coating procedure of DES are investigated, and the appropriate process parameters are gained. And then effects of preparation methods on property and drug release kinetics of sirolimus-loading DES are discussed, finally the reasons for different effects are theoretically analyzed in detail.
2. Mass loss and water intake rate of APC are studied in phosphate buffered saline (PBS). Poly(ethylene carbonate)(PEC) and poly(propylene ethylene carbonate)(PPEC) are preferably chosen as stent coating materials according to the experimental results. Then the excellent biocompatibilities of PEC and PPEC are preliminarily demonstrated by in vitro cytotoxicity test (MTT assay), hemolysis test and partial thromboplastin time test (PTT).
3. PPEC is synthesized by ethylene oxide (EO), propylene oxide (PO) and carbon dioxide (CO2) and catalyzed by glutaric zinc (ZnGA). Then in vitro feasibility studies of the utility of PEC and PPEC as coating materials for drug-eluting stent are reported. All the experimental results demonstrate that drug-loading APC coating stents have broad application prospects.
4. Factors to affect drug release of DES are researched in vitro. The factors include drug free polymer, drug gradient layer, the mass ratio of carrier and drug, different drug carriers and drug release medium. The results can optimize the design of biodegradable drug carrier and DES.
引文
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