Processing of Materials for Improved Biocompatibility

材料加工以提高生物相容性

• 批准号: 6612923
• 负责人: MICHAEL A. MATTHEWS
• 金额: $ 46.8万
• 依托单位: UNIVERSITY OF SOUTH CAROLINA AT COLUMBIA
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-07-15 至 2005-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6612923
• 关键词: antiseptic sterilization; bioengineering /biomedical engineering; biofilm; biomaterial compatibility; biomaterials; carbon dioxide; ceramics; endotoxins; implant; metals; polymers; prosthesis; surface property; thermodynamics

DESCRIPTION (provided by applicant): This Bioengineering Research Partnership (BRP) will conduct basic research to improve biocompatibility of materials used in biomedical devices such as prostheses and implants by providing a higher level of cleanliness and decontamination, while simultaneously providing sterilization. The BRP will determine the effectiveness of dense phase (liquid or compressed gas) carbon dioxide fluid technology for enhancing biocompatibility. The multidisciplinary partnership is led by the Department of Chemical Engineering at the University of South Carolina and includes two university partners; the Medical University of South Carolina and Clemson University, assisted by outside experts on surface preparation of implants and industrial applications of supercritical fluid based technology. A three-year BRP effort is proposed: Year 1 will confirm whether, and under what conditions, dense phase CO2 is an effective medium for sterilizing and cleaning common biomaterials and will focus on simple solid metallic, polymer, or ceramic coupons, using three typical microorganisms for tests of sterilization effectiveness and by processing samples that have been contaminated with known particulates (graphite, polyperfluoroethylene, and iron oxide) to determine the effectiveness of particulate removal and cleaning. Finally, tests to determine whether the materials treated with CO2, show improved resistance to bacterial adhesion and biofilm formation will be conducted. Year 2 research will focus on complex materials, namely flexible polymers (polyurethane and silicone rubber), as well as porous monoliths of titanium. Also in Year 2, the BRP will examine the material surface to search for adverse effects of CO2 processing, such as corrosion, pitting, and embrittlement. These experiments provide data needed for process optimization and permit comparison to known material/surface damage caused by existing cleaning and sterilization methods. Year 3 will focus on process design and optimization through the use of process design models and testing of representative devices (artificial joint, stent, and catheter) with CO2 under optimized conditions and determine the integrity and biocompatibility of the device. Also during Year 3, the ability of C02 processing to clean, decontaminate, and sterilize will be tested in vitro for material biocompatibility using cell culture methods and in vivo for histocompatibility using a subcutaneous implantation animal model.

描述（由申请人提供）：该生物工程研究合作伙伴关系（BRP）将进行基础研究，通过提供更高水平的清洁度和净化，同时提供灭菌，来提高假体和植入物等生物医学设备中使用的材料的生物相容性。BRP将确定密相（液体或压缩气体）二氧化碳流体技术用于增强生物相容性的有效性。多学科合作由南卡罗来纳州大学化学工程系领导，包括两所大学合作伙伴;南卡罗来纳州医科大学和克莱姆森大学，并由植入物表面制备和超临界流体技术工业应用方面的外部专家协助。建议开展为期三年的《两年期快速恢复计划》工作： 第1年将确认密相CO2是否以及在何种条件下是用于灭菌和清洁常见生物材料的有效介质，并将重点关注简单固体金属、聚合物或陶瓷试样，使用三种典型微生物进行灭菌有效性测试，并处理已被已知颗粒污染的样品（石墨、聚全氟乙烯和氧化铁），以确定微粒去除和清洁的有效性。最后，将进行测试以确定用CO2处理的材料是否显示出对细菌粘附和生物膜形成的改进的抗性。 第二年的研究将集中在复杂材料，即柔性聚合物（聚氨酯和硅橡胶），以及钛的多孔整体。同样在第2年，BRP将检查材料表面，以寻找CO2处理的不利影响，如腐蚀、点蚀和脆化。这些实验提供了工艺优化所需的数据，并允许与现有清洁和灭菌方法引起的已知材料/表面损伤进行比较。 第3年将通过使用过程设计模型和在优化条件下使用CO2对代表性器械（人工关节、支架和导管）进行试验，重点关注过程设计和优化，并确定器械的完整性和生物相容性。同样在第3年期间，将使用细胞培养方法在体外测试CO2处理的清洁、去污和灭菌能力，以确定材料的生物相容性，并使用皮下植入动物模型在体内测试组织相容性。