Microhook nerve tape: A nerve repair coaptation aid

项目摘要 我们将完成基于微型钩的设备的开发， 修复神经损伤。这种“微型钩神经带”由一系列微型钩组成， 分布在一个精细的，灵活的网络中，并嵌入生物背衬中。这款设备将 在神经修复手术中代替显微缝合线用于包裹和捆绑 切断的神经的接近的末端（或神经移植物的末端）。短微型钩 只渗透到神经的外部结缔组织层，形成有效的 机械连接并在整个装置上均匀分布张力。微型钩神经带 与当前临床应用相比， 显微缝合修复的标准。微型钩神经胶带应用的简便性和直观性 将实现一致的高质量修复，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，生产了一套由不锈钢制成的原型。 层压在猪小肠粘膜生物层内的钢基微钩网片 （SIS）。在生物力学测试中，神经被该装置固定在一起，强度与 显微缝合修复的方法在体内兔子测试中，该装置被植入物良好耐受。 周围组织和用微钩神经带切割和修复的神经再生 神经缝合与显微缝合修复神经。我们随后开发了一种增强型镍钛合金- 基于版本的设备更适合于临床翻译，我们证明了上级 该器械在生物力学测试中的性能。 在第二阶段，我们将完成微钩神经胶带装置的设计， 微型钩，我们将开发高效的制造和生产方法。我们将 在全面的家兔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- 经批准的神经修复器械，可存放在货架上，以便在神经修复期间使用 程序.微钩神经胶带将减少神经的技术要求和时间成本 维修，同时提高维修的一致性和整体质量.

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.