Microhook nerve tape: A nerve repair coaptation aid

 描述（由申请人提供）：该拟议项目将开发和验证一种基于微型钩的神经胶带器械，用于快速有效地修复神经损伤。微型钩包裹物由一系列微型钩组成，分布在精细、柔性的网状结构中，并嵌入生物相容性背衬材料中。这种神经胶带将在神经修复手术中代替显微缝合线用于缠绕和捆绑切断神经的接合端。短的微型钩仅穿透神经的外部结缔组织层，形成类似于VelcroTM品牌产品的有效机械连接。这种机械连接将张力均匀地分布在整个包裹物上，并且可以快速、可重复地应用，而无需手术显微镜或广泛的显微外科培训。与目前的临床标准显微缝合修复相比，微钩神经胶带有可能降低整体手术成本，并促进神经损伤后的恢复。第一阶段将优化微钩神经胶带的设计，并验证其安全性和有效性。具体而言，目标1将测试微型钩的各种配置、背衬材料和闭合方法。目标2将使用人尸体神经和兔植入模型的生物力学测试来验证神经包裹物接合神经外膜组织而没有慢性炎症或对再生轴突的负面影响的能力。第二阶段将包括功能结局指标的广泛动物和临床试验，制造工艺的建立，以及最终的510 k批准和许可/分销协议。最终产品将是FDA批准的“微钩神经胶带”材料，可以储存在货架上，供神经修复手术期间使用。一旦包装成商业医疗器械，微型钩包装将降低医疗成本，同时改善患者的可及性和恢复质量。

 DESCRIPTION (provided by applicant): This proposed project will develop and validate a microhook-based nerve tape device for quick and effective repair of nerve injuries. The microhook wrap consists of an array of microscale hooks, distributed across a fine, flexible meshwork and embedded in a biocompatible backing material. This nerve tape will be used during nerve repair surgeries in place of microsutures to wrap around and bind the coapted ends of a severed nerve. The short microhooks penetrate only into the outer, connective tissue layers of the nerve, forming an effective mechanical connection akin to VelcroTM brand products. This mechanical connection distributes tension evenly across the wrap and can be applied quickly, and reproducibly, without the need for a surgical microscope or extensive microsurgical training. Versus the current clinical standard microsuture repair, microhook nerve tape has the potential to reduce overall surgical costs and enhance recovery after nerve injuries. Phase I will optimize the design of microhook nerve tape and validate its safety and efficacy. Specifically, Aim 1 will test various configurations of microhooks, backing materials, and closure methods. Aim 2 will use biomechanical testing on human cadaver nerves and rabbit implantation models to validate the ability of the nerve wrap to engage epineurial tissue without chronic inflammation or negative effect on regeneration axons. Phase II will include extensive animal and clinical testing of functional outcome measures, establishment of manufacturing processes, and ultimately 510k approval and licensing/distribution agreements. The final product will be an FDA-approved "microhook nerve tape" material that can be stored on the shelf for use during nerve repair procedures. Once packaged as a commercial medical device, microhook wrap will reduce healthcare costs while improving patient access and quality of recovery.