NSF/FDA Scholar in Residence Program on Physico-Chemical Characterization and In Vitro Biological Evaluation of 3D Printed Ceramics

NSF/FDA 3D 打印陶瓷物理化学表征和体外生物学评估常驻学者项目

• 批准号: 2037636
• 负责人: Roger Narayan
• 金额: $ 10万
• 依托单位: North Carolina State University
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2037636&HistoricalAwards=false
• 关键词: NSF; FDA; Scholar; Residence; Program; NSF; FDA; Scholar; Residence; Program

Non-Technical Summary: This Scholar-in-Residence project will seek to better understand two new types of 3D printed bone replacements that are based on an inert bioceramic material, zirconia, and a biodegradable bioceramic material, calcium phosphate. Calcium phosphate is a compelling material for bone replacement implants (e.g., synthetic bone grafts) since it stimulates bone formation on the surface of medical device. A new type of calcium phosphate material will be 3D printed, which contains a gradient between (a) a form of calcium phosphate that rapidly releases bone-stimulating chemicals and (b) a form of calcium phosphate that can serve as long-lasting interface between an implant and the surrounding bone. Since zirconia surfaces with micro- and nano-roughened features exhibit better bone integration properties than smooth zirconia surfaces, a new type of patterned zirconia biomaterial will be created by 3D printing and laser texturing. A collaboration between NC State University and FDA researchers will seek to understand the relationships among the bioceramic processing parameters, physical properties, chemical properties, mechanical properties, and in vitro biological responses for the novel 3D printed ceramics. The results of this project will reduce knowledge gaps related to 3D printed ceramics and will lead to new types of synthetic bone grafts, which will provide an improved quality of life for patients who suffer from various orthopedic conditions. Science Saturday lectures and hands-on activities will disseminate results from the project to elementary school students, middle school students, high school students, and other visitors to the North Carolina Museum of Natural Sciences. Information on recent advances in medical 3D printing, including results from this project, will be disseminated to teachers across the state of North Carolina via an online workshop series.Technical Summary: The project will take advantage of the unique capabilities at NC State University related to processing and characterization of novel biomaterials and at the FDA related to biological characterization of novel biomaterials to systematically evaluate fabrication, post processing (e.g., patterning and sterilization), and the biological response to two new types of 3D printed bioceramics, patterned zirconia and functionally gradient calcium phosphate. Phase I of the project will involve understanding the physico-chemical properties of the 3D printed patterned zirconia and functionally gradient calcium phosphate parts. For example, scanning electron microscopy and atomic force microscopy will be used to assess the reproducibility and uniformity of the surface features of the 3D printed bioceramics. X-ray diffraction and X-ray photoelectron spectroscopy will be used to examine the microstructure and the presence of impurities in the 3D printed bioceramics, respectively. Phase II of the project will involve the use of nanoindentation and four-point bend testing to understand the mechanical properties of the 3D printed bioceramics. Phase III of the project will utilize FDA facilities to evaluate interactions between application-relevant cells (e.g., bone marrow stromal cells and osteoblast-like cells) and the 3D printed bioceramics through protein absorption, cell adhesion dynamics, cell morphology, cell proliferation, and osteogenic differentiation studies. This proposal is unique in that the PI team will systematically evaluate fabrication, post processing, material characteristics, mechanical properties, and biological response to two new types of 3D printed bioceramics. The data obtained in this Scholar-in-Residence project will be relevant to the development of 3D printed bioceramic medical devices and the improvement of international consensus standards that facilitate regulatory decision-making for 3D printed medical devices.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.

非技术摘要：这个居住的学者项目将寻求更好地理解基于惰性生物陶瓷材料，氧化锆和可生物降解的生物陶瓷材料，磷酸钙的两种新型3D印刷骨替代品。磷酸钙是骨替代植入物（例如合成骨移植物）的引人注目的材料，因为它刺激了医疗器械表面上的骨形成。一种新型的磷酸钙材料将是3D印刷，其中包含（a）一种磷酸钙形式之间的梯度，该形式迅速释放出骨刺激性化学物质，（b）磷酸钙的一种形式，可以用作植入物与周围骨骼之间的持久界面。由于与光滑的氧化锆表面相比，带有微型和纳米式特征的锆表面具有更好的骨整合特性，因此将通过3D打印和激光纹理创建一种新型的图案化氧化锆生物材料。 NC州立大学与FDA研究人员之间的合作将寻求了解新型3D印刷陶瓷的生物陶瓷加工参数，物理特性，化学性质，机械性能以及体外生物学反应之间的关系。该项目的结果将减少与3D印刷陶瓷有关的知识差距，并将导致新型的合成骨移植物，这将为患有各种骨科状况的患者提供改善的生活质量。科学星期六的讲座和动手活动将使该项目的结果传播给小学生，中学生，高中生以及北卡罗来纳州自然科学博物馆的其他访客。有关医疗3D打印最新进展的信息，包括该项目的结果，将通过在线研讨会系列中向北卡罗来纳州的教师分解。技术摘要：该项目将利用NC州立大学的独特功能，与新型生物材料的处理和针对FDA的处理以及新颖的生物形式的生物学表征（与新颖的生物学表征）相关的NC州立大学的独特功能（灭菌），以及对两种新型3D印刷生物陶瓷，图案化氧化锆和功能梯度磷酸钙的生物学反应。该项目的第一阶段将涉及理解3D印刷的图案化氧化锆的物理化学特性和功能性梯度磷酸钙部分。例如，扫描电子显微镜和原子力显微镜将用于评估3D印刷杀菌剂的表面特征的可重复性和均匀性。 X射线衍射和X射线光电子光谱将分别用于检查3D印刷生物陶瓷中的微观结构和杂质的存在。该项目的第二阶段将涉及使用纳米凹痕和四点弯曲测试来了解3D打印生物陶瓷的机械性能。该项目的第三阶段将利用FDA功能来评估相关的细胞（例如骨髓间隙细胞和成骨细胞样细胞）和3D印刷生物辅酶通过蛋白质吸收，细胞粘附动力学，细胞形态，细胞增殖和稳定性分化研究。该提案的独特之处在于，PI团队将系统地评估对两种新型3D印刷生物陶瓷类型的制造，材料特征，机械特性以及生物学反应。该居住项目中获得的数据将与3D印刷的生物陶瓷医疗设备的开发以及改进国际共识标准的改进，这些标准有助于3D印刷的医疗设备的监管决策。这奖反映了NSF的立法任务，并被认为是通过基金会的智力评估的评估来评估的，并且值得通过基础的智力效果和广泛的范围进行评估。