AIR Option 1: Technology Translation A Microwave Assisted Biomimetic Coating Technology for Polymer Implants

AIR 选项 1：技术转化 用于聚合物植入物的微波辅助仿生涂层技术

• 批准号: 1312211
• 负责人: Sarit Bhaduri
• 金额: $ 15万
• 依托单位: University of Toledo
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-06-01 至 2018-05-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1312211&HistoricalAwards=false
• 关键词: AIR; Option; Technology; Translation; Microwave

This PFI: AIR Technology Translation project focuses on translating previously developed fundamental science to coat orthopedic implants made out of polymers with bioactive coatings. With the increasing clinical acceptance of Polyetheretherketone (PEEK) implants, there is an urgent need in the industry to develop low-temperature coating processes. The translated biomimetic coating technology has several distinctive features. First, being a low temperature benign process, it is eminently suitable for coating polymeric substrates such as PEEK implants. Second, the process has the ability to produce carbonated-calcium-deficient hydroxyapatite (CDHA), similar in composition to bone mineral and a bioactive variation of inert hydroxyapatite. Third, unlike conventional biomimetic processes spanning over several weeks, the deposition of the coating takes place within a relatively short time frame of less than an hour, thus providing the ability for large scale industrial production. All of these features taken together make the technology more versatile than conventional coating processes. This project accomplishes the broad objective of fabricating the coatings and evaluating them for their physical, mechanical, and biomedical properties in vitro and in vivo; data essential to obtain approval from the various regulatory agencies, like the FDA. This effort is a "Win-Win" situation for both the partners: The University of Toledo and Orchid Bio-coat (Orchid) will work with the University of Toledo's Technology Transfer Office to bring the technology to market. The partnership engages Orchid to provide guidance to UT in the overall manufacturing, translation, distribution and further commercialization aspects that will introduce to the market a new generation of bioactive orthopedic implants made out of PEEK. Orchid is one of the nation's largest providers of plasma sprayed coatings on titanium implants with their distribution network all across the globe. However, with the switch from metallic to polymeric implants, UT will be able to provide the "turn-key" technology. The potential economic impact is expected to be felt within next three years' time frame, which will contribute to the U.S. competitiveness in this orthopedic implant space.This project has a significant societal impact on the ageing "Baby Boomers" and an increasingly active general population. These segments of the society, which are growing at a very fast rate, experience the most musculoskeletal diseases and injuries. This population is expected to require a wide variety of implants. In the U.S., the orthopedic reconstructive device/implant market is presently experiencing an annual growth rate of 12 to 14%, which is even higher than that of the spinal implant market, growing at 10%. This proposal will address this demand by developing improved and novel products with enhanced integration of the implant with the adjoining boney surfaces. The effort will also train qualified manpower and will cater to the needs of implant manufacturers.

该PFI：AIR技术翻译项目的重点是将先前开发的基础科学转化为用生物活性涂层涂覆由聚合物制成的骨科植入物。随着聚醚醚酮（PEEK）植入物的临床接受度不断提高，行业迫切需要开发低温涂层工艺。翻译仿生涂层技术有几个鲜明的特点。首先，作为一种低温良性工艺，它非常适合涂覆聚合物基材，如PEEK植入物。第二，该工艺能够生产碳酸化缺钙羟基磷灰石（CDHA），其组成与骨矿物质相似，是惰性羟基磷灰石的生物活性变体。第三，与跨越数周的常规仿生工艺不同，涂层的沉积在小于一小时的相对短的时间范围内发生，从而提供了大规模工业生产的能力。所有这些特点加在一起使该技术比传统的涂层工艺更通用。该项目实现了制造涂层并评估其体外和体内物理，机械和生物医学特性的广泛目标;获得FDA等各监管机构批准所必需的数据。这一努力对双方来说是一个“双赢”的局面：托莱多大学和兰花生物涂层（兰花）将与托莱多大学的技术转让办公室合作，将技术推向市场。该合作伙伴关系让Orchid在整体制造、翻译、分销和进一步商业化方面为UT提供指导，这将向市场推出由PEEK制成的新一代生物活性骨科植入物。 Orchid是美国最大的钛植入物等离子喷涂涂层供应商之一，其分销网络遍布地球仪。 然而，随着从金属植入物到聚合物植入物的转变，UT将能够提供“交钥匙”技术。潜在的经济影响预计将在未来三年内感受到，这将有助于美国在骨科植入物领域的竞争力。该项目对老龄化的“婴儿潮一代”和日益活跃的普通人群产生重大的社会影响。 这些社会阶层正在以非常快的速度增长，经历了最多的肌肉骨骼疾病和伤害。预计该人群需要多种植入物。 在美国，矫形重建装置/植入物市场目前正经历12 - 14%的年增长率，这甚至高于脊柱植入物市场的年增长率，脊柱植入物市场的年增长率为10%。 该提案将通过开发改进的新型产品来满足这一需求，该产品具有增强的植入物与相邻骨表面的整合。 这项工作还将培训合格的人力，并满足植入物制造商的需求。