SBIR Phase II: Biofabrication of a collagen fabric by scaled-up electrochemical compaction

这个小企业创新研究（SBIR）二期项目的更广泛的社会影响/商业潜力是通过使用新材料来支持生物功能来改善临床护理。本项目将开发一种用于软组织修复和支持的各种外科植入物的材料。本项目专门开发了一种用于治疗女性压力性尿失禁和盆腔器官脱垂的吊带植入物。这些情况会导致严重的功能丧失和生活质量下降。目前的解决方案是聚丙烯网状植入物，它会导致诸如疼痛和网状物暴露等不良事件。胶原蛋白比聚丙烯具有更强的生物相容性，应该产生相同的结果，不良事件更少。从长远来看，这种生物织物的其他应用包括骨科修复、疝气治疗、神经再生和普通外科的植入物。这项小型企业创新研究（SBIR）二期项目旨在扩大生产工艺规模，生产一种由电压实胶原蛋白线制成的新型生物织物。这种生物织物具有高度的生物相容性，诱导积极的组织反应，并且吸收缓慢。提出的技术进步包括开发更高速度和吞吐量的设备和工艺来制造线和生物织物。该项目推进了与规模化生产相关的制造过程，并创建了验证和确认程序。该奖项反映了美国国家科学基金会的法定使命，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 societal impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is to improve clinical care through the use of new materials to support biological functions. This project will develop a material for a variety of surgical implants for soft tissue repair and support. This project specifically develops a sling implant for the treatment of stress urinary incontinence and pelvic organ prolapse in women. These conditions cause significant loss of function and quality of life. The current solution, polypropylene mesh implants, can cause adverse events such as pain and mesh exposure. Collagen is more biocompatible than polypropylene and should produce equivalent outcomes with fewer adverse events. In the longer term, other applications for this biofabric include implants for orthopedic repairs, hernia treatment, nerve regeneration, and general surgery. This Small Business Innovation Research (SBIR) Phase II project seeks to scale up the manufacturing process for producing a novel biofabric made from electrocompacted collagen threads. This biofabric is highly biocompatible, induces a positive tissue response, and resorbs slowly. The technical advances proposed include the development of higher speed and throughput equipment and processes to manufacture the thread and biofabric. This project advances the manufacturing process associated with scaled production, as well as creating the verification and validation procedures.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.