Pre-Clinical Optimization of MeniscoFix, a Novel Total Meniscus Replacement Implant

半月板损伤是最常见的膝关节内损伤之一，导致超过75万人受伤 在美国，每年都有外科手术。切除撕裂的组织，称为半月板切除术，通常 提供疼痛、不适和不稳定的短期缓解，但改变了关节的机械性能，使 潜在的软骨易患长期的骨性关节炎。目前还没有FDA批准的植入物 半月板置换手术。我们的方法是用机械功能的半月板替换撕裂或退变的半月板。 替代性植入物MeniscoFixTM，能够在改建成功能性植入物的同时被缓慢吸收， 保护软骨的新半月板组织。 该项目第一阶段的目标是优化用于临床的MeniscoFix™植入技术的设计。 用于内侧和外侧半月板，满足解剖、生物力学和功能要求。 目标1：优化内侧和外侧半月板的MeniscoFixTM设计。 将使用SolidWorks和有限元分析(FEA)来设计和筛选纤维增强模板 内侧半月板和外侧半月板种植体，它们在解剖、大小、形状和根部附着位置上有所不同。 基于有限元模拟，最佳地满足解剖和生物力学设计要求的设计 将被选择用于后续制造和初步设计验证，包括拉伸、压缩、 根据ASTM F3223-17进行粘弹性和循环测试。 目的#2：添加放射状纤维以降低种植体挤出的风险。原型目前由以下公司制造 使用数控机床堆叠多个二维(X-Y)纤维增强图案。我们现在将评估 径向或Z方向的各种纤维增强模式，以潜在地改善生物力学性能 并降低种植后种植体挤出的风险。 目的#3：手术固定所需的植入物‘尾部’的机械加固。一种新的设计 植入物的尾部区域将得到改进，以提供坚固的骨内手术固定，同时保持 植入物的完整性，降低胫骨附着部位松动或断裂的风险。 还将进行初步设计验证研究，以确保MeniscoFix™满足 最终用户。矫形外科的主要意见领袖将评估MeniscoFixTM的可用性特征 通过在人类身体膝盖上进行关节镜辅助的半月板置换手术。 这些SBIR项目里程碑的成功实现将进一步降低技术风险并改进 与老牌整形外科医疗设备制造商合作的机会。最终目标是 为骨科医生提供一种新颖、安全和有效的治疗方案，以恢复和保持质量 对患有不可修复的半月板损伤或半月板切除术后综合征的患者的生命的影响。

Meniscal injuries represent one of the most common intra-articular knee injuries, resulting in over 750,000 surgical procedures in the United States annually. Removal of the torn tissue, known as meniscectomy, typically provides short-term relief from pain, discomfort, and instability, but alters the joint’s mechanics, leaving the underlying cartilage susceptible to long-term osteoarthritis. There is currently no FDA-approved implant for total meniscus replacement. Our approach is to replace torn or degenerated menisci with a mechanically functional replacement implant, MeniscoFixTM, capable of being slowly absorbed while remodeling into functional, chondroprotective neo-meniscal tissue. The goal of this Phase I SBIR project is to optimize the design of the MeniscoFix™ implant technology for clinical use in both the medial and lateral meniscus, addressing anatomical, biomechanical, and functional requirements. Aim #1: Optimization of MeniscoFixTM designs for use in both the medial and lateral meniscus. SolidWorks with finite element analysis (FEA) will be used to design and screen fiber reinforcement patterns for medial meniscus and lateral meniscus implants, which differ in anatomy, size, shape, and root attachment sites. Based on FEA simulations, designs which optimally satisfy anatomical and biomechanical design requirements will be selected for subsequent manufacturing and preliminary design verification including tensile, compressive, viscoelastic, and cyclic testing per ASTM F3223-17. Aim #2: Addition of radial fibers to reduce risk of implant extrusion. Prototypes are currently made by stacking multiple 2-dimensional (X-Y) fiber reinforcement patterns using a CNC machine. We will now evaluate various fiber reinforcement patterns in the radial or ‘Z-direction’ to potentially improve biomechanical properties and reduce the risk of implant extrusion after implantation. Aim #3: Mechanical reinforcement of the implant ‘tail region’ required for surgical fixation. The design of the tail region of the implant will be improved to provide for rigid intra-osseous surgical fixation while maintaining implant integrity, reducing risks of loosening or breakage at the tibial attachment sites. Preliminary design validation studies will also be performed to ensure MeniscoFix™ satisfies the needs of the end user. Key Opinion Leaders in Orthopaedic Surgery will evaluate usability characteristics of MeniscoFixTM by performing arthroscopically-assisted meniscus replacement procedures in human cadaver knees. Successful achievement of these SBIR project milestones will further de-risk the technology and improve opportunities to partner with established Orthopaedic medical device manufacturers. The ultimate goal is to provide Orthopaedic surgeons with a novel, safe, and effective treatment option to restore and maintain quality of life in patients suffering from irreparable meniscal injuries or post-meniscectomy syndrome.