Novel manufacturing process and material development for an innovative load bearing hydrogel for use in orthopedic implants

Orthonika是伦敦帝国理工学院（Imperial College London）的一家中小型企业（SME）分拆公司，该公司开发了用于骨科植入物的新型承重聚合物材料，目前正计划将制造从实验室转移到生产环境。这些令人兴奋的材料有可能解决与软组织损伤相关的关键医疗挑战，例如需要进行膝关节全半月板置换术（TMR）。水凝胶一直被认为是软组织置换的极有前途的材料，可能为骨科植入物开辟新市场。然而，它们的采用受到机械性能差和断裂韧性低的阻碍。Orthonika的新型水凝胶具有令人印象深刻的机械性能和断裂韧性，上级目前用于骨科应用的标准交联PVA水凝胶，甚至优于关节软骨本身。TMR旨在解决高度未满足的临床需求-尽管半月板损伤的发病率很高，治疗的选择是有限的，并且目前对严重损伤的半月板的护理标准是部分或完全切除。不幸的是，这种手术已知会产生额外的问题，缺乏半月板是骨关节炎的主要风险因素，骨关节炎是一种与关节软骨异常磨损相关的慢性和使人衰弱的关节疾病，影响了英国400多万人。据估计，50%的半月板部分切除术患者因此被诊断为骨关节炎。Orthonika的产品复制了天然半月板的结构和功能，提供了一种耐用的设备，可以以最小的侵入性植入并牢固地固定在骨上，以承受剧烈的体力活动-这是目前严重半月板损伤患者无法使用的选择。该解决方案填补了姑息治疗实践和全膝关节置换术之间的临床护理空白，恢复膝关节功能并预防骨关节炎的发生。在氧气空隙环境中放大复杂的自由基聚合过程，同时结合预成型的解剖学形状的超高分子量聚乙烯纤维增强材料，将解决许多技术挑战。Orthonika将这项工作的部分内容分包给总部位于英国的Contamac，Contamac是一家经验丰富且屡获殊荣的隐形眼镜和人工晶状体聚合物供应商，已有30多年的历史。我们将共同规划和开发一个强大的制造工艺和质量管理体系，以确定材料和植入物是否符合我们严格的目标规格。如果成功地大规模生产我们的新型水凝胶，我们可以解决其他骨科器械的机会。

Orthonika, an SME spin-out from Imperial College London, has developed novel load-bearing polymer materials for use in orthopaedic implants and is now planning to transfer manufacturing from the bench into a production environment. These exciting materials have the potential to address key healthcare challenges associated with soft tissue injuries such as the need for a total meniscus replacement (TMR) in the knee.Hydrogels have long been thought of as highly promising materials for soft tissue replacements, potentially opening up new markets for orthopaedic implants. Their adoption, however, has been hampered by poor mechanical properties and low fracture toughness. Orthonika's novel hydrogel has impressive mechanical properties and a fracture toughness that is superior to the standard crosslinked PVA hydrogels currently in use for orthopaedic applications, and even to the articular cartilage itself.The TMR seeks to address a high unmet clinical need - despite the high prevalence of meniscus injury, treatment options are limited and today's standard of care for a severely damaged meniscus is partial or complete removal. Unfortunately, this procedure is known to create additional problems and lack of a meniscus is a major risk factor for osteoarthritis, a chronic and debilitating joint condition associated with abnormal wear of articular cartilage, affecting more than 4 million people in the UK. An estimated 50% of partial meniscectomy patients are diagnosed with osteoarthritis as a result.Orthonika's product replicates the structure and function of the natural meniscus, providing a durable device that can be implanted with minimal invasion and fixed securely to the bone to withstand the rigor of physical activity - an option not currently available to patients with severe meniscus injury. This solution fulfils a clinical care gap between palliative care practices and total knee replacement, restoring knee function and preventing the onset of osteoarthritis.A number of technological challenges will be addressed in scaling-up a complex free radical polymerisation process in an oxygen void environment whilst incorporating a pre-formed anatomically shaped ultra-high molecular weight polyethylene fibre-reinforcement. Orthonika is sub-contracting elements of this work to UK-based Contamac, an experienced and award-winning supplier of polymers for contact and intraocular lenses for over 30 years. Together we will plan and develop a robust manufacturing process and quality management system to establish whether material and implant can meet our rigorous target specifications.If successful in manufacturing our novel hydrogel at scale, we can address other orthopaedic device opportunities.