Microhook nerve tape: A nerve repair coaptation aid

 描述(申请人提供)：这项拟议的项目将开发和验证一种基于微钩的神经胶带装置，用于快速有效地修复神经损伤。微钩包裹由一组微尺度的钩组成，分布在精细、灵活的网络中，并嵌入生物兼容的衬底材料中。这种神经胶带将在神经修复手术中用来代替显微缝线，以包裹和捆绑被切断的神经的粘连末端。短小的微钩只能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包裹上，可以快速、可重复地施加，而不需要手术显微镜或广泛的显微外科培训。与目前临床标准的显微缝合修复相比，微钩神经胶带有可能降低整体手术成本，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。具体地说，AIM 1将测试各种配置的微钩、衬垫材料和闭合方法。目的2将在人身体神经和兔植入模型上进行生物力学测试，以验证神经包裹与神经外膜组织结合的能力，而不会出现慢性炎症或对再生轴突产生负面影响。第二阶段将包括对功能结果衡量标准进行广泛的动物和临床测试，建立制造工艺，并最终达成510k批准和许可/分销协议。最终的产品将是FDA批准的“微钩神经胶带”材料，可以储存在货架上，供神经修复过程中使用。一旦包装成商业医疗设备，微钩包裹将降低医疗成本，同时改善患者接触和康复质量。

 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.