FDA Scholar Program: Characterizing Leaching of Hazardous Material from Polymeric Biomaterials

FDA 学者计划：表征聚合生物材料中有害物质的浸出

• 批准号: 2149517
• 负责人: Martin Tanaka
• 金额: $ 9.98万
• 依托单位: Western Carolina University
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-05-01 至 2023-06-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2149517&HistoricalAwards=false
• 关键词: FDA; Scholar; Program; Characterizing; Leaching

Potentially hazardous chemicals contained within implanted medical devices can pose a risk to human health if they migrate from the device into surrounding tissues. However, if the amount of chemicals released in one day is low, the exposure may have little to no risk of negative effects. Historically, the primary method to predict the amount of exposure has been through laboratory testing in chemical liquids. However, recent advances in science and computer technology support the development of new computer-based tools to predict exposure risk. In this research, mathematical equations and computer simulations are developed to predict how quickly potentially hazardous materials are released into the body. An advancement over previous simulations is the inclusion of both the medical device and the surrounding tissue in a two-component model designed to better predict exposure risk. Predictive models can reduce development cost, decrease animal testing, and enable products to reach the market faster without sacrificing public protection. Use of the model for preliminary risk assessment would be a great asset to industry, especially small companies that may lack the resources to predict outcomes prior to engagement with regulatory bodies. As an additional component, the principal investigator will visit medical device companies to share knowledge about the product evaluation process, develop a new course, and provide undergraduates with funded research opportunities.The goal of this research is to more accurately quantify the rate that leachable materials are released from a medical device by modeling their migration through a polymeric matrix and the contacting biological tissue. Research includes characterizing the transport properties of leachables in biological tissue by aggregating data from multiple sources and using cluster analysis to approximate transport properties of leachables in biological tissue. Mathematical models and computer simulations that utilize these transport properties will be created to predict migration of leachables using a diffusion-limited two-component system. In addition, a novel approach to model biomaterial systems will be developed that represent model parameters as probability density functions rather than single scalar values. This new approach will advance modeling tools available in this field. Overall, this research will improve the fundamental understanding of the fate of leachables contained within polymeric biomaterials in contact with the body. Physics-based models that better capture the complexities of this system will yield more clinically relevant results than extraction studies, expanding our understanding of these complex biodynamic systems.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.

植入医疗设备中含有的潜在危险化学物质如果从设备迁移到周围组织，可能会对人类健康构成风险。然而，如果一天释放的化学物质量较低，则接触可能几乎没有或没有负面影响的风险。从历史上看，预测接触量的主要方法是通过化学液体的实验室测试。然而，科学和计算机技术的最新进展支持开发新的基于计算机的工具来预测暴露风险。在这项研究中，开发了数学方程和计算机模拟来预测潜在危险物质释放到体内的速度。与之前的模拟相比，一个进步是将医疗设备和周围组织纳入双组件模型中，旨在更好地预测暴露风险。预测模型可以降低开发成本，减少动物测试，并使产品更快地进入市场，而无需牺牲公共保护。使用该模型进行初步风险评估对于行业来说是一笔巨大的财富，尤其是那些在与监管机构接触之前可能缺乏资源来预测结果的小公司。作为额外的组成部分，首席研究员将访问医疗器械公司，分享有关产品评估过程的知识，开发新课程，并为本科生提供受资助的研究机会。这项研究的目标是更准确地量化可浸出材料的比率通过模拟它们通过聚合物基质和接触的生物组织的迁移，从医疗设备中释放它们。研究包括通过聚合多个来源的数据来表征生物组织中浸出物的传输特性，并使用聚类分析来近似生物组织中浸出物的传输特性。将创建利用这些传输特性的数学模型和计算机模拟，以使用扩散限制的双组分系统来预测可浸出物的迁移。 此外，还将开发一种建模生物材料系统的新方法，将模型参数表示为概率密度函数而不是单个标量值。这种新方法将改进该领域可用的建模工具。总体而言，这项研究将提高对与人体接触的聚合生物材料中所含浸出物的命运的基本了解。基于物理的模型能够更好地捕捉该系统的复杂性，将产生比提取研究更多的临床相关结果，从而扩大我们对这些复杂的生物动力系统的理解。该奖项反映了 NSF 的法定使命，并通过使用基金会的智力评估进行评估，被认为值得支持。优点和更广泛的影响审查标准。