NSF/FDA Scholar-In-Residence at FDA: Program on Small-Scale Medical Devices

NSF/FDA FDA 常驻学者：小型医疗器械项目

• 批准号: 1041375
• 负责人: Roger Narayan
• 金额: $ 13万
• 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: 2010
• 资助国家: 美国
• 起止时间: 2010-11-01 至 2013-10-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1041375&HistoricalAwards=false
• 关键词: NSF; FDA; Scholar; Residence; Program

1041375NarayanConventional ossicular replacement prostheses have demonstrated several problems during clinical use, including migration, puncture of the eardrum, difficulty in shaping the prostheses, and reactivity with the surrounding tissues. Novel materials and prostheses that provide improved sound transmission for longer periods of time are demanded by patients and surgeons. In this work, they hypothesize that two photon polymerization may be used to fabricate ossicular replacement prostheses with patient-specific designs and suitable chemical, biological, mechanical, and functional properties for long-term in vivo use. The quadratic character of the two photon absorption probability and the well-defined polymerization threshold of this system will allow one to overcome the diffraction limit and achieve features as small as 200 nm. Two photon polymerization provides several advantages over conventional techniques for scalable production of ossicular replacement prostheses and other small-scale medical devices. First, the raw materials used in this process are widely available and inexpensive. Second, two photon polymerization can be set up in a conventional clinical environment (e.g., an operating room) that does not contain cleanroom facilities. Third, two photon polymerization of ossicular replacement prostheses is an rapid, straightforward, single-step process, as opposed to conventional multiple-step fabrication techniques.

1041375 Narayan传统的听骨置换假体在临床使用中已经证明了几个问题，包括移位、鼓膜穿孔、假体成形困难以及与周围组织的反应性。患者和外科医生需要提供更长时间的改善声音传输的新型材料和假体。在这项工作中，他们假设双光子聚合可以用于制造具有患者特定设计和合适的化学，生物，机械和功能特性的听骨置换假体，用于长期体内使用。该系统的双光子吸收概率的二次特性和明确定义的聚合阈值将允许人们克服衍射极限并实现小至200 nm的特征。双光子聚合提供了优于常规技术的几个优点，用于听骨置换假体和其他小规模医疗装置的可规模生产。首先，这一过程中使用的原材料广泛可用且价格低廉。第二，双光子聚合可以在常规的临床环境（例如，手术室）不包含洁净室设施。第三，与传统的多步骤制造技术相反，听骨置换假体的双光子聚合是快速、直接、单步过程。