Enhanced Biocompatibility of NiTi (NITINOL) via Surface Treatment and Alloying

通过表面处理和合金化增强镍钛 (NITINOL) 的生物相容性

• 批准号: 7876898
• 负责人: Norman Donald Munroe
• 金额: $ 10.88万
• 依托单位: FLORIDA INTERNATIONAL UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-08-29 至 2012-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7876898
• 关键词: Adhesions; Adsorption; Age; Alloys; American; American Heart Association; Angioplasty; Applied Research; Arteries; Behavior; Biocompatible Materials; Biological; Blood; Blood Clot; Blood Platelets; Blood coagulation; Cell Proliferation; Coronary; Corrosion; Coupled; Elements; Endothelial Cells; Food; Future; Generations; Growth; Health; Heart Diseases; Implant; In Vitro; Incidence; Indium; Industry; Inflammation Mediators; Kidney; Leukocytes; Liver; Longevity; Materials Testing; Medical; Medical Device; Metals; Methods; Monitor; Necrosis; Patients; Performance; Peripheral; Pharmaceutical Preparations; Plasma; Proteins; Raman Spectrum Analysis; Resistance; Roentgen Rays; Safety; Sales; Sampling; Societies; Stents; Surface; System; Tantalum; Testing; Thrombosis; biomaterial compatibility; carcinogenicity; cell growth; comparative; design; experience; flexibility; improved; in vitro testing; in vivo; nitinol

DESCRIPTION (provided by applicant): It is projected that by 2015 there will be 133 million Americans over 45, the age at which the increased incidence of heart diseases is documented. Many will require stents (small metal-mesh sleeves implanted in unclogged arteries by angioplasty). This multi-billion dollar industry, with over 2 million patients worldwide, 15% of whom use Nitinol (a NiTi Alloy) stents, has experienced a decline in sales recently, due in part to Thrombosis in about two out of 1000 per year in stable patients with relatively simple artery blockage. Thrombosis is a sudden blood clot that forms inside drug-eluting stents. As a result, the Food and Drug Adminstration, the American Heart Association, and others are calling for a new generation of stents, new designs and different alloys that are more flexible and more adaptable to the arteries. The future of Nitinol as a biomaterial therefore depends on a better understanding of mechanisms by which Nitinol surface can be rendered stable and inert, yet retain flexibility and machinability. Additionally, Ni enrichment and its leaching from the Nitinol surface must be controlled due to its carcinogenicity and deleterious effects in the liver and kidney. Ni also causes necrosis. Therefore, I propose to conduct standard American Society of Testing and Materials (ASTM) potentiodynamic and potentiostatic corrosion tests on the ternary alloys of Nitinol (Ni51Ti49)1-xTax system in the range of 0-20 atomic % Ta to evaluate the corrosion resistance in biological media. Ta, added as a ternary element in the NiTi-alloys, has been proven to impart X-ray visibility, stability, corrosion resistance and other beneficial effects. Inductively Coupled Plasma Analysis will be used to monitor Ni release in biological media. Biocompatibility will be assessed by observing the growth of cells on the material's surface and exploring blood compatibility [platelet spreading, protein adsorption, cell proliferation, inflammatory mediators, etc.] The Nitinol surfaces will be characterized using XRD, DSC, EPMA, Raman Spectroscopy, SEM, etc. I am of the opinion that this applied research effort could improve upon the in-vivo safety and performance profile of NiTi as used in coronary and peripheral arteries, as well as in bodily passageways where the alloy is subjected to corrosivity extremes, ultimately resulting in the even more widespread efficacious medical use of advanced Nitinol alloys

描述（由申请人提供）：预计到2015年，将有1.33亿美国人超过45岁，即心脏病发病率增加的年龄。许多人需要支架（血管成形术植入未淹没的动脉中的小金属网袖）。这个数十亿美元的行业，全世界有超过200万名患者，其中15％使用NITINOL（一种NITI合金）支架，最近销售量下降，部分原因是稳定的动脉阻塞的稳定患者中，每年约有1000名中有2个。血栓形成是一种突然的血凝块，在吸毒支架内形成。结果，食品和药物管理，美国心脏协会以及其他人呼吁新一代的支架，新设计和不同的合金，这些合金更灵活，更适合动脉。因此，奈蒂诺作为生物材料的未来取决于对奈蒂诺表面可以稳定和惰性的机制的更好理解，但保持了灵活性和可加工性。此外，由于其致癌性和肝脏和肾脏的有害作用，必须控制Ni富集及其从奈蒂诺表面的浸出。 NI还会导致坏死。因此，我建议在0-20 Atomic％TA范围内对NITINOL（NI51TI49）1-XTAX系统的三元合金（NI51TI49）的三元合金进行标准的电型动力学和电静脉腐蚀测试，以评估生物学培养基中的腐蚀性。 TA是NITI-Alys中的三元元素，已被证明可以赋予X射线可见性，稳定性，耐腐蚀性和其他有益作用。电感耦合等离子体分析将用于监测生物介质中的NI释放。生物相容性将通过观察材料表面上的细胞生长并探索血液相容性[血小板扩散，蛋白质吸附，细胞增殖，炎症介质等]的表面将使用xrd，dsc，dsc，epma，epma，raman spem，我的意见来改善nitinol表面，以改进努力，以改善努力的努力。用于冠状动脉和外围动脉，以及合金受到极端腐蚀性的体验通道，最终导致更广泛的有效医疗用途。