STTR Phase I: Investigating Self-powered Health Monitoring of Orthopedic Implants and Data Retrieval Using Diagnostic Ultrasound

这个小型企业技术转移（STTR）一期项目的广泛影响和商业潜力将是一个重大转变，将反应性骨科手术转变为主动、预防性和成本效益高的手术。该项目将对骨科手术实践质量产生直接的积极影响，同时显著降低社会成本。根据2013年的全国调查，接受骨科手术的患者中有25%对其骨科手术结果表示不满意。更糟糕的是，如果骨科植入物发生灾难性的故障，患者会遭受巨大的痛苦，并且在召回有缺陷的植入物和复杂的修复手术上花费了大量的费用。缺乏数据驱动的决策工具，可用于外科医生在骨科手术期间和之后是由于目前无法持续监测？身体健康吗?骨科植入物。这种缺失工具的创造将使外科医生能够合理判断何时可以最佳移除创伤固定装置或何时可以最佳地进行翻修手术。该项目的主要影响将是：1。减轻患者不适；2. 减少骨科医疗费用；3. 减少因翻修手术延迟和住院时间过长造成的社会成本；4. 提高骨科术后康复水平。拟议的项目将使用专利的自供电压电浮动门（PFG）传感技术开发骨科植入物的健康监测传感系统。该方案解决了骨科手术中一个长期存在的技术挑战，以创造一个主动和预防性的骨科手术体验。外科医生在创伤手术后经常被问到的一个关键问题是询问患者的骨愈合进展情况，这是一个今天几乎不知道的常见问题。x光通常不能给外科医生提供骨折愈合程度的全面、准确和持续的评估。PFG传感器的一个关键特点是使用浮门传感电路，计算和存储应变率和应力的累积统计数据，同时达到任何竞争健康和使用传感技术无法实现的操作功率限制。该传感器需要不到一微瓦的功率，可以很容易地从在应变模式（而不是振动模式）下工作的微型压电传感器中获得。这将使无电池、自供电的PFG传感器能够植入体内或附着在骨科植入物上。这种PFG传感器将为创伤外科医生提供定量信息，使其能够就骨愈合进展做出可操作的决策，并在需要时及时计划翻修手术。

The broader impact/commercial potential of this Small Business Technology Transfer (STTR) Phase I project will be a significant transformation-changing reactive orthopedic surgery into proactive, preventive and cost-effective surgery. The project will have a direct positive impact on the quality of orthopedic surgery practice while reducing significant social costs. According to 2013 national survey, 25% of the patients who underwent orthopedic surgery reported dissatisfaction with their orthopedic surgical outcomes. Even worse, patients suffered great pain if the orthopedic implants experienced catastrophic failures and extensive costs have been spent on the recall of the defective implants and complex revision surgeries. The lack of a data- driven, decision-making tool available to surgeons during and after orthopedic surgery is created by the current inability to continuously monitor ?physical health? of orthopedic implants. Creation of this missing tool will empower surgeons to make reasonable judgment as to when trauma fixation devices can be optimally removed or when revision surgery can be optimally timed. The key impacts of the project will be: 1. Reduction of patients discomfort; 2. Reduction of orthopedic healthcare costs; 3. Reduction of social costs due to delayed revision surgery and endured long hospital stays; 4. Improvement of post orthopedic surgery rehabilitation. The proposed project will develop a health monitoring sensing system for orthopedic implants using a patented self-powered piezo-floating-gate (PFG) sensing technology. This proposal tackles a long-standing technical challenge in orthopedic surgery to create a proactive and preventive orthopedic surgery experience. A key question often asked of surgeons after trauma surgery is an inquiry on the patients bone healing progress - a common question that is nearly unknowable today. X-rays generally do not give surgeons a full, accurate and continuous assessment of the extent of healing of bone fractures. A key feature of the PFG sensor is the use of floating-gate sensing circuits that compute and store cumulative statistics of the strain- rates and stresses while achieving operational power limits not possible with any competing health and usage sensing technologies. The sensor requires less than one microwatt of power that can be easily harvested from a miniature piezoelectric transducer operating in strain-mode (not vibration-mode). This will enable batteryless, self-powered PFG sensors to be implanted inside the body or attached to orthopedic implants. This PFG sensor would empower trauma surgeons with quantitative information to enable actionable decisions regarding bone-healing progress, and to plan timely revision surgery if needed.