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膝关节内损伤之一， 美国每年的外科手术。切除撕裂的组织，称为阑尾切除术，通常 提供短期缓解疼痛，不适和不稳定，但改变了关节的力学， 对长期骨关节炎敏感的潜在软骨。目前还没有FDA批准的植入物 半月板置换术我们的方法是用机械功能性的 置换植入物MeniscoFixTM能够在重塑为功能性时缓慢吸收， 软骨保护性新骨组织。 该I期SBIR项目的目标是优化MeniscoFix™植入物技术的设计， 用于内侧和外侧半月板，满足解剖学、生物力学和功能要求。 目标#1：优化用于内侧和外侧半月板的MeniscoFixTM设计。 SolidWorks与有限元分析（FEA）将用于设计和筛选纤维增强模式， 内侧半月板和外侧半月板植入物，其在解剖结构、尺寸、形状和根部附着部位上不同。 基于FEA模拟，设计最佳满足解剖和生物力学设计要求 将被选择用于随后的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。 目标#2：添加径向纤维以降低植入物挤出的风险。原型目前由 使用CNC机器堆叠多个二维（X-Y）纤维增强图案。我们现在将评估 径向或“Z方向”上的各种纤维增强图案，以潜在地改善生物力学性能 并降低植入后植入物挤出的风险。 目标3：手术固定所需的植入物“尾部区域”的机械加固。的设计 植入物的尾部区域将被改进以提供刚性的骨内手术固定 植入物完整性，降低胫骨连接部位松动或断裂的风险。 还将进行初步设计确认研究，以确保MeniscoFix™满足 最终用户。骨科的主要意见领袖将评价MeniscoFix？的可用性特征 通过在人类尸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， 有机会与知名的Orthopathy医疗器械制造商合作。最终目标是 为骨科医生提供了一种新颖、安全、有效的治疗选择，以恢复和保持质量 在患有不可修复的尿道损伤或尿道切除术后综合征的患者中，