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

这项创新-技术转化伙伴关系（PFI-TT）项目的更广泛影响/商业潜力是了解用于医疗植入物的镁（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生物可降解的植入物，用于修复骨折和其他医疗用途，因为它们在骨愈合后溶解，只留下天然的骨成分。几乎30%的金属植入物，如不锈钢，由于并发症或需要容纳仍在成长的孩子，必须在后期移除。使用镁合金的好处是不需要第二次手术，大大降低了护理成本、手术风险和患者压力。与技术商业化专家合作，该PFI-TT项目将开发、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，并吸引本科生和高中生参与教育和研究项目。这种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需求，这种测试很容易在医生办公室进行。该项目旨在开发一种灵敏、选择性和快速响应的氢（H2）传感器，其形式为“创可贴”式装置，用于无创监测可生物降解的含镁植入物。常用的x射线技术对镁合金的检测效果很差，因为镁合金的密度与骨骼的密度非常接近，所以用x射线很难将镁合金植入物与骨骼区分开来。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，测量缓慢溶解的Mg通过皮肤渗透产生的低水平H2气体是完全独特的。本应用程序的目的是优化氢气传感器原型。中心假设是，H2传感器在暴露于H2时将非侵入性地引起颜色变化，并提供Mg植入物上方区域H2水平的视觉地图。这一假设是根据支持性的初步数据制定的。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。该奖项反映了美国国家科学基金会的法定使命，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.