I-Corps: Noninvasive Monitoring of Implantable Devices via Methacrylate-Modified Nanoparticles (NanoMA)

这个I-Corps项目的更广泛的影响/商业潜力是开发一个纳米材料平台，以实现对植入式医疗器械，特别是组织工程医疗产品的无创监测。研究人员、开发新产品的公司和合同研究组织目前还没有建立在体内临床前测试期间无创监测植入式器械功能的方法。目前在临床前试验中评估安全性和有效性的最佳实践是侵入性的，需要切除植入物进行体外破坏性试验，这使得临床前试验成为创新的一个极其昂贵和耗时的障碍。拟议的纳米材料平台将提供一种替代产品，克服这一障碍，显着减少监管负担（成本，时间和动物）面临潜在customers.This I-Corps项目是基于甲基丙烯酸酯改性纳米粒子（nanoMA）的发展作为纳米材料平台的植入式医疗器械的非侵入性监测。所提出的技术作为成像造影剂，以克服无法无创成像常见的支架生物材料，如水凝胶。NanoMA能够在一个步骤中连接到水凝胶，而不会破坏水凝胶功能，同时能够实现可调成像对比度，用于手术放置，生物降解和药物释放的非侵入性纵向监测。这些纳米颗粒被设计为与现有的支架生物材料无缝集成，无论是作为添加剂，还是与商业化的生物聚合物或生物墨水一起预先包装用于生物打印。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 I-Corps project is the development of a nanomaterial platform to enable noninvasive monitoring of implantable medical devices, especially tissue engineered medical products. Researchers, companies developing new products, and contract research organizations, currently have no established means to noninvasively monitor the function of implantable devices during in vivo preclinical testing. Current best practices for evaluating safety and efficacy in preclinical testing are invasive, requiring the excision of implants for destructive testing ex vivo making preclinical testing is an extremely costly and time-consuming barrier to innovation. The proposed nanomaterial platform will offer an alternative product that overcomes this barrier to significantly decrease the regulatory burden (cost, time, and animals) facing potential customers.This I-Corps project is based on the development of methacrylate-modified nanoparticles (nanoMA) as a nanomaterial platform for noninvasive monitoring of implantable medical devices. The proposed technology functions as imaging contrast agents to overcome the inability to noninvasively image common scaffold biomaterials such as hydrogels. NanoMA are able to be linked to hydrogels in one step, with no disruption to hydrogel function, while enabling tunable imaging contrast for noninvasive, longitudinal monitoring of surgical placement, biodegradation, and drug release. These nanoparticles are designed for seamless integration with existing scaffold biomaterials, either as an additive or prepackaged with commercialized biopolymers or bioinks for bioprinting.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.