SBIR Phase II: Customizable Meniscus Implant Prepared by Dielectrophoretic Biofabrication

这个小型企业创新研究二期项目旨在开发一个半月板植入物的原型，该半月板植入物是由细菌纤维素生物材料通过介电泳微编织制成的，这是一种创新的生物制造工艺。由xylinum醋酸杆菌产生的纳米纤维素网络是具有独特的水凝胶样特性和生物相容性的生物材料，是软骨组织替代的理想材料。这项技术是基于一种新的生物制造工艺，其中细菌的运动在电场中被精确控制，以形成所需形态的纳米纤维素网络。早期的可行性研究已经证明了细菌在电场中双轴运动时的纳米级纤维素沉积，以及控制纤维素层组装成任何所需三维结构和控制生物力学特性的能力。该二期项目将开发一种微编织生物反应器，用于根据患者的放射影像制作可定制的半月板植入物。将在膝关节模型中评估其结构和生物力学性能，并与天然半月板进行比较。生物相容性和长期性能将在大型动物模型研究中进行评估。如果二期项目成功，其更广泛的商业影响将是半月板植入物的可用性，该半月板植入物模仿自然半月板的结构，以解决膝关节故障，据估计，全球每年有1500多万人受到影响。在美国，每年有超过100万人接受半月板手术。不可修复的半月板损伤通常会进展并导致骨关节炎。目前，对于无法修复的半月板损伤，还没有令人满意的治疗方法。半月板植入物的潜在市场超过30亿美元。通过开发一种可以替代受伤的半月板的半月板植入物，将有可能预防骨关节炎及其相关的巨大经济成本。

This Small Business Innovation Research Phase II project aims to develop a prototype meniscus implant of bacterial cellulose biomaterials fabricated by dielectrophoretic microweaving, an innovative biofabrication process. Nano-cellulose networks produced by the bacteria Acetobacter xylinum are biomaterials with unique hydrogel-like properties and biocompatibility that are ideal for cartilage tissue replacement. This technology is based on a new biofabrication process, in which bacterial motion is precisely controlled in an electric field to form nano-cellulose networks of desired morphology. Earlier feasibility studies have demonstrated bacterial cellulose deposition at the nanoscale during biaxial motion of bacteria in an electric field and the ability to control the assembly of cellulose layers into any desired three-dimensional architecture and control biomechanical properties. This Phase II project will develop a microweaver bioreactor for fabrication of customizable meniscus implants based on radiology images from patients. The structure and biomechanical properties will be evaluated in knee-model and compared with native meniscus. Biocompatibility and long term performance will be evaluated in large animal model studies. The broader/commercial impact of this Phase II project, if successful, is the availability of meniscus implants that mimic the structure of the natural meniscus to address knee-joint failures, estimated to affect 15+ million people worldwide each year. Each year, in the US, more than 1 million people undergo meniscus surgery. Irreparable meniscus injuries often progress and lead to osteoarthritis. Currently, there is no satisfactory solution for irreparable meniscus injuries. The potential market for a meniscus implant is more than $3 billion. By developing a meniscus implant that can substitute for the injured native meniscus, it will be possible to prevent osteoarthritis and its related huge economic costs.