NSF/FDA Scholar in Residence Program on In Vitro Biological Characterization of 3D Printed Small-Scale Medical Devices

主要研究者：Narayan，Roger J.提案：1445727标题：NSF/FDA 3D打印小型医疗器械体外生物学特性的驻校学者项目意义本项目获得的数据将作为材料特性-生物学性能数据库的基础，其中将考虑体外细胞-材料相互作用、蛋白质吸附和材料加工参数之间的关系。监管科学方法将提供一系列方法和工具，以了解复杂和创新设备技术的基本组织-材料相互作用。技术说明在拟议的驻校学者（SIR）计划中，一种被称为多焦点双光子聚合的3D打印技术将被用于制造具有用于组织穿透和亚穿透的微尺度特征的固体组织倒刺粘合剂。用于氧化锆混合材料的细胞向内生长的微尺度特征。组织倒刺是一种创新的小型器械，在伤口闭合和愈合中具有潜在用途。他们将检查生物相容性光引发剂的使用（例如，核黄素-三乙醇胺混合物和核黄素-精氨酸混合物）用于基于双光子聚合的3D打印。他们还将评价电化学传感器的结合，以监测组织倒刺粘合剂中的肌酐。在拟议的计划中，他们将与FDA同事合作，使用适当的细胞（例如，真皮成纤维细胞和表皮角质形成细胞）。

PI: Narayan, Roger J.Proposal: 1445727Title: NSF/FDA Scholar in Residence Program on In Vitro Biological Characterization of 3D Printed Small-Scale Medical DevicesSignificanceThe data obtained in this project will serve as the basis for a material property-biological performance database, in which the relationship between in vitro cell-material interactions, protein adsorption, and material processing parameters will be considered. The regulatory science approach will provide a repertoire of methods and tools to understand the fundamental tissue-material interactions for complex and innovative device technologies.Technical DescriptionIn the proposed Scholar-in-Residence (SIR) program, a 3D printing technique known as multi-focus two photon polymerization will be used to create solid tissue barb adhesives with microscale features for tissue penetration and sub-microscale features for cell ingrowth out of a zirconium oxide hybrid material. Tissue barbs are innovative small-scale devices with potential use in wound closure and healing. They will examine use of biocompatible photoinitiators (e.g., riboflavin-triethanolamine mixtures and riboflavin-arginine mixtures) for two photon polymerization-based 3D printing. They will also evaluate incorporation of an electrochemical sensor for monitoring of creatinine within the tissue barb adhesive. In the proposed program, they will collaborate with FDA colleagues to evaluate the in vitro biocompatibility of tissue barb materials that contain sub-micrometer scale pores and creatinine sensor materials using appropriate cells (e.g., dermal fibroblasts and epidermal keratinocytes).