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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：
9141014
负责人：
Isaac Perry Clements
金额：
$ 15.65万
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 2017-09-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9141014
关键词：
Acute Adoption Adverse effects Agreement Animal Testing Animals Axon Back Binding Biocompatible Biological Biomechanics Cadaver Chronic Cicatrix Clinical Connective Tissue Development Device Designs Devices Elements Environment Equilibrium FDA approved Family suidae Fibrin Tissue Adhesive Geometry Growth Health Care Costs Human Implant Inflammation Injury Invaded Licensing Mechanics Medical Device Methods Microscope Microscopic Modeling Nerve Nerve Endings Nerve Regeneration Nerve Tissue Operative Surgical Procedures Oryctolagus cuniculus Outcome Outcome Measure Patients Peripheral Nerves Phase Physiological Procedures Recovery Reporting Research Safety Sampling Site Surgical sutures Techniques Technology Testing Time Tissues Training United States Validation Work axion axon regeneration base biomaterial compatibility comparative cost density design flexibility functional outcomes implantation improved manufacturing process nerve injury neurotropic novel prevent prototype public health relevance regenerative repaired research clinical testing research study stem tool

项目摘要

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.