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Microhook nerve tape: A nerve repair coaptation aid

Microhook 神经胶带：神经修复接合辅助工具

基本信息

批准号：
9750310
负责人：
Isaac Perry Clements
金额：
$ 28.63万
依托单位：
AXION BIOSYSTEMS, LLC
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-04-01 至 2019-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9750310
关键词：
Address Back Benchmarking Binding Biological Biomechanics Cadaver Chronic Cicatrix Clinical Complex Connective Tissue Custom Data Development Device Designs Device Safety Devices Elements Environment FDA approved Family suidae Injury Intuition Investments Mechanics Methods Microscopic Modeling Natural regeneration Nerve Nerve Regeneration Nerve Tissue Operative Surgical Procedures Oryctolagus cuniculus Outcome Paralysed Performance Phase Procedures Process Production Recovery Recovery of Function Risk Safety Secure Sensory Shapes Site Small intestine mucous membrane Speed Stainless Steel Surgeon Surgical sutures Techniques Technology Testing Time Tissues Training Treatment outcome Validation Work axion axon growth axon regeneration base biomaterial compatibility clinical translation commercialization constriction cost design experience flexibility implantation improved in vivo in vivo evaluation manufacturing process nerve injury nitinol prototype regenerative repaired safety testing simulation skills stem tissue trauma tool validation studies

项目摘要

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.

项目总结