Microhook nerve tape: A nerve repair coaptation aid

项目摘要 我们将最终完成基于微钩的设备的开发，以实现快速和一致的有效 神经损伤的修复。这种“微钩神经胶带”由一系列微型钩子组成， 分布在精细、灵活的网络中，并嵌入生物背衬中。这台设备将 在神经修复手术中用来代替微缝线来包裹和捆绑 切断的神经(或神经移植物的末端)的近端。短小的微钩 只穿透到神经的外部结缔组织层，形成有效的 机械连接，并在整个设备上均匀分配张力。微钩神经胶带 与目前的临床应用相比，可轻松应用并降低手术时间和复杂性 微缝合修补标准。微钩神经胶带应用的简便性和直观性 将实现始终如一的高质量修复，以优化神经损伤后的恢复。 在第一阶段，我们改进了设备设计，以生产一套由不锈钢组成的原型 猪小肠粘膜生物层内的钢基微钩网 (SIS)。在生物力学测试中，神经由该装置连接在一起，强度相当 到微缝合修复。在活体兔子测试中，该设备的耐受性良好 周围组织和神经被切断并用微钩神经胶带修复后再生 与显微缝合相比，修复的神经。我们随后开发了一种增强型镍钛醇- 基于版本的设备更适合于临床翻译，我们展示了优越的性能 该装置在生物力学测试中的性能。 在第二阶段，我们将最终完成以镍醇为基础的微钩神经胶带装置的设计 微钩，我们将开发高效的制造和生产方法。我们会 在全面的兔子研究中进行广泛的安全性和有效性验证测试 申请FDA 510(K)许可。最终的商业化产品将是FDA- 批准的神经修复装置，可存放在货架上，以供在神经修复期间使用 程序。微钩神经胶带将降低神经的技术要求和时间成本 维修，同时提高维修一致性和整体质量。

Project Summary We will finalize development of a microhook-based device for quick and consistently effective repair of nerve injuries. This “microhook nerve tape” consists of an array of microscale hooks, distributed across a fine, flexible meshwork and embedded in a biologic backing. This device will be used during nerve repair surgeries in place of microsutures to wrap around and bind the approximated ends of a severed nerve (or the ends of a nerve graft). The short microhooks penetrate only into the outer, connective tissue layers of the nerve, forming an effective mechanical attachment and distributing tension evenly across the device. Microhook nerve tape can be applied easily and lowers surgery time and complexity as compared to the current clinical standard of microsuture repair. The ease and intuitiveness of microhook nerve tape application will enable consistent high-quality repairs to optimize recovery after nerve injuries. In Phase I, we refined the device design to produce a set of prototypes consisting of a stainless steel-based microhook mesh laminated within a biologic layer of porcine small intestinal mucosa (SIS). In biomechanical testing, nerves were held together by the device with strength comparable to that of microsuture repairs. In in vivo rabbit testing, the device was well tolerated by the surrounding tissue, and nerves that were cut and repaired with microhook nerve tape regenerated comparably vs. microsuture repaired nerves. We subsequently developed an enhanced Nitinol- based version of the device more suitable to clinical translation, and we demonstrated the superior performance of this device in biomechanical testing. In Phase II we will finalize the design of the microhook nerve tape device with Nitinol-based microhooks, and we will develop efficient manufacturing and production methods. We will conduct extensive validation testing of safety and efficacy in comprehensive rabbit studies and apply for FDA 510(k) clearance. The final commercialization-ready product will be an FDA- approved nerve repair device that can be stored on the shelf for use during nerve repair procedures. Microhook nerve tape will reduce the technical demands and time costs of nerve repair, while improving repair consistency and overall quality.