SBIR Phase I: Preclinical Development and Mechanical Testing of a Load Transfer Implant (LTI) for Knee Joint Arthroplasty

SBIR 第一阶段：用于膝关节置换术的负载转移植入物 (LTI) 的临床前开发和机械测试

• 批准号: 1248362
• 负责人: Jessee Hunt
• 金额: $ 15万
• 依托单位: 4-Web Spine Inc.
• 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: 2013-01-01 至 2013-12-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1248362&HistoricalAwards=false
• 关键词: SBIR; Phase; Preclinical; Development; Mechanical

This Small Business Innovation Phase I project is focused on a novel knee replacement technology that employs leading edge manufacturing processes that enable production of unique device structures designed to improve bone-device interaction and eliminate the need for revision procedures. This technology utilizes engineering principles such as load transfer and truss design to improve bone integration with a Total Knee Replacement (TKR) implant. Additive layer manufacturing technology, or computer aided fused titanium rapid prototyping, can be used to produce an innovative TKR implant that incorporates innovative web truss geometries for the bone interface component. It is anticipated that the web structure will provide improved initial fixation, reduce micro motion, and eliminate aseptic loosening. This project is designed to further optimize and measure the operating parameters and durability of the device through mechanical testing outlined in the FDA'S Guidance Document for TKR implants. Experiments will include fatigue testing, constraint testing, contact area testing, kinematic modeling and fixation testing. It is anticipated that this device design will represent a significant advancement in knee replacement technology that is substantially more stable and resistant to failure as compared to existing devices. The broader impact/commercial potential of this project are evident in that Knee Arthritis is a debilitating condition that leads to over 600,000 TKR?s per year. The TKR currently represents approximately 8% of all Medicare spending. Total hospital charges for this procedure are expected to approach $40 billion by 2012. Revision rates for TKR's are significant; 10% at 10 years and 20% at 20 years. Moreover, with an aging population, the number of TKR's and revisions is steadily increasing; of which, a majority will be completed under Medicare coverage. This project will accelerate production of an innovative device that employs state-of-the-art manufacturing processes and structural engineering design principles to substantially improve the bone/TKR implant interface. The design of the device has been optimized to address the problems associated with initial and long-term fixation and could thereby reduce or eliminate the need for revision procedures. This would benefit the healthcare economy and the quality of life for those that require knee replacement therapy. Furthermore, this project is part of an educational initiative that includes researchers at Texas A&M University that are employing this technology in providing unique educational experiences for graduate students in advancing engineering principles in medical device design.

该小型企业创新I期项目的重点是一种新型膝关节置换技术，该技术采用先进的制造工艺，能够生产独特的器械结构，旨在改善骨-器械相互作用并消除翻修手术的需要。该技术利用负荷转移和桁架设计等工程原理，改善骨与全膝关节置换（TKR）植入物的结合。增材层制造技术或计算机辅助熔融钛快速成型可用于生产创新的TKR植入物，该植入物结合了骨界面组件的创新网状桁架几何形状。预计网状结构将改善初始固定，减少微动，并消除无菌性松动。本项目旨在通过FDA全膝关节置换术植入物指南文件中概述的机械测试，进一步优化和测量器械的操作参数和耐久性。实验将包括疲劳测试、限制测试、接触面积测试、运动学建模和固定测试。预计该器械设计将代表膝关节置换技术的重大进步，与现有器械相比，其稳定性和抗失效性显著提高。该项目更广泛的影响/商业潜力是显而易见的，因为膝关节炎是一种使人衰弱的疾病，导致超过600，000例TKR？s每年。TKR目前约占所有医疗保险支出的8%。预计到2012年，这一程序的医院费用总额将接近400亿美元。TKR的翻修率显著; 10年为10%，20年为20%。 此外，随着人口老龄化，TKR和翻修的数量正在稳步增加;其中大部分将在医疗保险范围内完成。 该项目将加速创新器械的生产，该器械采用最先进的制造工艺和结构工程设计原则，以大幅改善骨/TKR植入物界面。 该器械的设计已经过优化，以解决与初始和长期固定相关的问题，从而减少或消除翻修手术的需求。这将有利于医疗保健经济和那些需要膝关节置换治疗的人的生活质量。此外，该项目是一项教育计划的一部分，该计划包括德克萨斯A M大学的研究人员，他们正在利用这项技术为研究生提供独特的教育经验，以推进医疗器械设计中的工程原理。