PFI-TT: Development of a visual sensor to non-invasively monitor biodegradable magnesium alloy implants for biomedical applications

该创新-技术转化合作伙伴关系（PFI-TT）项目的更广泛影响/商业潜力是了解医疗植入物中使用的镁（Mg）合金的生物降解，并为患者术后评估提供所需的诊断传感器。镁合金越来越多地用于可生物降解的植入物，用于修复骨折和其他医疗应用，因为它们在骨愈合后溶解，只留下天然的骨成分。近30%的金属植入物（如不锈钢）由于并发症或需要容纳仍在生长的儿童而必须在以后取出。使用镁合金的好处是不需要二次手术，显著降低了护理成本、手术风险和患者压力。该PFI-TT项目与技术商业化专家合作，将开发、测试和优化拟议的传感器原型，以监测实验室和动物环境中含镁植入物的生物降解，促进创新和创业教育，并让本科生和高中生参与教育和研究计划。该传感器具有商业潜力，因为它满足了这个不断增长的市场对生物降解过程的简单诊断测试的未满足的需求，该测试可以在医生的办公室轻松进行。拟议的项目旨在开发一种灵敏，选择性和快速响应的氢（H2）传感器，以“创可贴”类型的设备的形式，用于非侵入性监测可生物降解的含镁植入物。通常可用的X射线技术对镁合金效果不佳，因为镁的密度与骨的密度非常接近，以至于镁植入物不能通过X射线容易地与骨区分开。因此，迫切需要一种监测镁合金生物降解的方法。为了监测Mg植入物的生物降解，对渗透皮肤的缓慢溶解的Mg产生的低水平H2气体进行测量是完全独特的。本申请的目的是优化H2传感器原型。中心假设是，当暴露于H2时，H2传感器将非侵入性地引起颜色变化，并提供Mg植入物上方区域的H2水平的视觉图。这一假设是根据支持性初步数据制定的。其基本原理是，研究人员将深入了解传感器的整体设计，这是传感器商业化的重要一步，用于无创监测患者体内含镁植入物的生物降解。该奖项反映了NSF的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact/commercial potential of this Partnerships for Innovation - Technology Translation (PFI-TT) project is to understand the biodegradation of magnesium (Mg) alloys used in medical implants and to provide a needed diagnostic sensor for post-surgery evaluation of patients. Mg alloys are increasingly used in biodegradable implants for repairing broken bones and other medical applications because they dissolve after the bone is healed, leaving only the natural bone components. Almost 30% of metal implants such as stainless steel must be removed later due to complications or the need to accommodate a still-growing child. The beneficial aspect of using Mg alloys is that a second surgery is not needed, significantly reducing costs of care, surgery risk, and patient stress. Partnering with a technology commercialization expert, this PFI-TT project will enable development, testing, and optimization of the proposed sensor prototype to monitor the biodegradation of Mg-containing implants in both a laboratory and animal setting, promote education in innovation and entrepreneurship, and engage undergraduate and high school students into educational and research programs. This sensor has commercial potential because it fulfills the unmet need in this growing market for a simple diagnostic test for biodegradation progress that is easily performed in a doctor’s office.The proposed project aims to develop a sensitive, selective and fast-response hydrogen (H2) sensor in the form of a “Band-Aid” type device for the non-invasive monitoring of biodegradable Mg-containing implants. Commonly available X-ray technology works poorly for Mg alloys, because the density of Mg is so close to that of bone that the Mg implants cannot be easily distinguished from bone by X-ray. Thus, there is a critical need for a method to monitor the biodegradation of Mg alloys. Measurement of the low level of H2 gas from the slowly dissolving Mg permeating through skin for the purpose of monitoring the biodegradation of Mg implants is completely unique. The objective of this application is to optimize the H2 sensor prototype. The central hypothesis is that the H2 sensor will non-invasively cause a color change when exposed to H2 and provide a visual map of H2 levels over an area above the Mg implant. This hypothesis is formulated based on the supporting preliminary data. The underlying rationale is that the researchers will obtain insight into the overall design of the sensor, which is an essential step toward commercialization of the sensor for non-invasive monitoring of biodegradation of Mg-containing implants in patients.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.