Improved long-term biocompatibility of coronary stents by plasma coating process

描述(申请人提供)：通过等离子涂层工艺改善冠状动脉支架的长期生物相容性摘要药物洗脱支架(DES)因其比裸金属支架(BMS)更好的控制再狭窄的能力而被广泛用于心脏病患者的治疗。然而，在接受DES治疗的患者中，晚期支架血栓形成的严重不良后果已被报道，即使发生率很低，也会导致致命的心脏病发作和死亡。因此，为了安全和有效的临床使用，冠状动脉支架需要在其表面具有更好的生物相容性，在抑制细胞增殖的同时还将提供足够的抗血栓能力，从而减缓支架周围组织的愈合。Nanova公司正在开发一种在制造冠状动脉支架的金属生物材料表面上具有高抗血栓性能的新型涂层。低温等离子体工艺是一种环保技术，用于沉积超薄(纳米级)但连续的涂层，足以产生所需的耐磨性，并固定在随后的等离子体表面处理中产生的生物活性官能团，以防止血栓和再狭窄，但足够薄，允许支架扩张，在进入患者体内时不会破裂。从这一创新研究项目中获得的知识也将有助于研究和开发其他植入式医疗设备，如起搏器、脉冲发生器、心脏除颤器和生物传感器，以改善生物兼容性。 公共卫生意义：Nanova公司正在开发一种新的冠状动脉支架涂层工艺，以防止冠状动脉再狭窄和晚期支架内血栓(支架内的血块)，用于治疗冠心病，这将使美国100多万患者受益。

DESCRIPTION (provided by applicant): Improved long-term biocompatibility of coronary stents by plasma coating process Abstract Drug-eluting stents (DES) have been widely used to treat patients of cardiac disease due to their better ability to control restenosis than bare metal stents (BMS). However, a serious adverse outcome of late stent thrombosis in patients treated with DES has been reported, which leads to fatal heart attack and death even though it occurs at low rate. Thus, for safe and effective clinical use, a coronary stent needs to have better biocompatibility on its surface that will provide sufficient thrombo-resistance in addition to inhibiting cell proliferation thereby slowing down healing of tissues around the stent. Nanova, Inc. is developing a novel coating layer of high thrombo-resistance on the surface of metallic biomaterials of which coronary stents are made. An environmentally benign technology, low temperature plasma process is used to deposit an ultra-thin (nano-scale) but continuous layer of coating, sufficient to generate desired abrasion resistance and immobilize the bioactive functional groups created in the subsequent plasma surface treatment to prevent blood clots and restenosis, but thin enough to allow for stent expansion without cracking when delivered into patients. The knowledge gained in this innovative research project will also benefit research and development for improved biocompatibility in other implantable medical devices such as pacemakers, pulse generators, cardiac defibrillators and bio-sensors. PUBLIC HEALTH RELEVANCE: Nanova, Inc. is developing a novel coating process on coronary stents to prevent both restenosis of coronary arteries and late in-stent thrombosis (blood clots in stents) for treatment of coronary heart disease, which will benefit over one million of patients in the United States.