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转化先前开发的基础科学，为由聚合物制成的骨科植入物涂上生物活性涂层。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。翻译过来的仿生涂层技术有几个显着的特点。首先，作为一种低温良性工艺，它非常适合涂覆聚合物基材，例如 PEEK 植入物。其次，该过程能够生产碳酸化缺钙羟基磷灰石（CDHA），其成分与骨矿物质相似，并且是惰性羟基磷灰石的生物活性变体。第三，与传统的仿生工艺需要几周的时间不同，涂层的沉积发生在不到一个小时的相对较短的时间内，从而提供了大规模工业生产的能力。所有这些功能加在一起使该技术比传统涂层工艺更加通用。该项目实现了制造涂层并在体外和体内评估其物理、机械和生物医学特性的广泛目标；数据对于获得 FDA 等各个监管机构的批准至关重要。这一努力对于合作双方来说是一个“双赢”的局面：托莱多大学和 Orchid Bio-coat (Orchid) 将与托莱多大学的技术转让办公室合作，将该技术推向市场。此次合作让 Orchid 为 UT 的整体制造、翻译、分销和进一步商业化方面提供指导，从而向市场推出由 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，其分销网络遍布全球。 然而，随着从金属植入物转向聚合物植入物，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显现出来，这将有助于提高美国在骨科植入领域的竞争力。该项目对老龄化的“婴儿潮一代”和日益活跃的普通人口具有重大的社会影响。 这些正在快速增长的社会群体遭受最多的肌肉骨骼疾病和伤害。预计该人群需要各种各样的植入物。 在美国，骨科重建器械/植入物市场目前的年增长率为12%至14%，甚至高于脊柱植入物市场的10%的增长率。 该提案将通过开发改进的新颖产品来满足这一需求，增强植入物与相邻骨表面的集成。 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。