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

这个小企业创新第一阶段项目的重点是一种新的膝关节置换技术，该技术采用了领先的制造工艺，能够生产出独特的设备结构，旨在改善骨-设备的相互作用，消除对修改程序的需要。该技术利用负荷转移和桁架设计等工程原理来改善全膝关节置换术（TKR）植入物的骨整合。增材层制造技术或计算机辅助熔融钛快速成型技术可用于生产创新的TKR植入物，该植入物将创新的网状桁架几何形状用于骨界面组件。预计网板结构将提供更好的初始固定，减少微运动，并消除无菌性松动。该项目旨在通过FDA TKR植入物指导文件中概述的机械测试进一步优化和测量设备的操作参数和耐用性。实验将包括疲劳测试，约束测试，接触面积测试，运动学建模和固定测试。预计该装置的设计将代表膝关节置换术技术的重大进步，与现有装置相比，它具有更大的稳定性和抗失效性。该项目的广泛影响/商业潜力是显而易见的，因为膝关节关节炎是一种使人衰弱的疾病，导致超过600,000 TKR？每年5美元。TKR目前约占所有医疗保险支出的8%。到2012年，这项手术的医院总收费预计将接近400亿美元。TKR的修正率显著；10年10% 20年20%此外，随着人口老龄化，TKR的数量和修订数量正在稳步增加；其中大部分将在医疗保险覆盖范围内完成。该项目将加速创新设备的生产，该设备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。该装置的设计已经过优化，以解决与初始和长期固定相关的问题，从而减少或消除对翻修程序的需要。这将有利于医疗经济和生活质量的那些需要膝关节置换治疗。此外，该项目是一项教育计划的一部分，包括德克萨斯农工大学的研究人员，他们正在利用这项技术为研究生提供独特的教育体验，以推进医疗设备设计的工程原理。

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.