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

MeniscoFix（一种新型全半月板置换植入物）的临床前优化

• 批准号: 10547466
• 负责人: Kevin S Weadock
• 金额: $ 27.55万
• 依托单位: NOVOPEDICS, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-07-15 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10547466
• 关键词: Achievement; Address; Anatomy; Award; Benign; Biomechanics; Cadaver; Cartilage; Characteristics; Clinical; Clinical Treatment; Clinical Trials; Collagen; Data; Degenerative polyarthritis; Development; Devices; Ensure; Evaluation; Excision; FDA approved; Failure; Feasibility Studies; Female; Fiber; Finite Element Analysis; Generations; Goals; Human; Hyaluronic Acid; Implant; Joints; Knee; Knee Injuries; Lateral; Lateral meniscus structure; Legal patent; Manufacturer Name; Mechanics; Medial; Medial meniscus structure; Medical Device; Meniscus structure of joint; Methods; Operative Surgical Procedures; Orthopedic Surgery; Orthopedics; Patients; Pattern; Performance; Periodicity; Phase; Plant Roots; Polymers; Procedures; Property; Psychological reinforcement; Quality of life; Radial; Risk; Shapes; Sheep; Site; Small Business Innovation Research Grant; Stress; Surgeon; Syndrome; Tail; Technology; Testing; Tissue Engineering; Tissues; United States; Ursidae Family; Wood material; articular cartilage; base; clinically significant; commercialization; design; design verification; effective therapy; efficacy study; first-in-human; healing; high risk; implant design; implantation; improved; innovation; knee replacement arthroplasty; male; manufacturing process; mechanical load; medical schools; meniscal tear; meniscus injury; neglect; next generation; novel; pain relief; phase 2 study; pre-clinical; preclinical safety; preclinical study; prevent; prototype; risk minimization; safety study; sample fixation; severe injury; simulation; skills; two-dimensional; usability; validation studies; verification and validation; viscoelasticity

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.

半月板损伤是最常见的关节内膝关节损伤之一，导致超过750,000 每年在美国的手术程序。去除撕裂的组织，称为半月切除术，通常是 从疼痛，不适和不稳定中提供短期缓解，但改变了关节的机制，使人离开 易受长期骨关节炎的潜在软骨。目前没有FDA批准的植入物可用于总计 半月板替代。我们的方法是用机械功能的替换或退化的半月板 替换植入物，bemisofixtm，能够在重塑功能时缓慢吸收， 软骨保护新验证组织。 I阶段I SBIR项目的目标是优化临床的Meniscofix™植入技术的设计 在培养基和外侧弯月面中使用，以解决解剖学，生物力学和功能要求。 目的＃1：在媒体和横向半月板中使用的半月板设计设计。 具有有限元分析（FEA）的实体工程将用于设计和筛选纤维增强模式 半月板和外侧弯板叉，它们的解剖学，大小，形状和根附着位点不同。 基于FEA模拟，最佳满足解剖学和生物力学设计要求的设计 将选择以后的制造和初步设计验证，包括拉伸，压缩， 每ASTM F3223-17的粘弹性和循环测试。 目标＃2：添加径向纤维以降低植入物扩展的风险。原型目前由 使用CNC机器堆叠多个二维（X-Y）纤维增强型图案。我们现在将评估 径向或“ z方向”中的各种纤维增强模式，以改善生物力学特性 并降低植入后植入物扩展的风险。 目标＃3：手术固定所需的植入物“尾部区域”的机械加固。设计 将改进植入物的尾部区域，以提供固定的骨内手术固定固定 植入物完整性，降低胫骨附着位点放松或破裂的风险。 还将进行初步设计验证研究，以确保ManiScoFix™满意度的需求 最终用户。骨科手术中的关键意见领导者将评估半月板的可用性特征 通过在人体尸体膝盖中执行关节辅助的半月板替代程序。 这些SBIR项目里程碑的成功实现将进一步降低技术并改善 与已建立的骨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，安全且有效的治疗选择，以恢复和保持质量 患有不可弥补的半月板损伤或结肠切除术后综合征的患者的生命。