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.
Public Health Relevance Statement: Public Health Relevance: This project will develop a microhook-based nerve tape material for wrapping around and holding together the two ends of a cut nerve. The distributed array of microscopic hooks bind strongly to the outer tissue layers without penetrating to the delicate interior. This repair can be performed quickly and effectively and has the potential to improve nerve regeneration. Microhook nerve tape will lower the time and cost of nerve repair surgeries and enhance patient recovery from debilitating nerve injuries.
NIH Spending Category: Bioengineering; Neurosciences
Project Terms: Acute; Adoption; Adverse effects; Agreement; Animal Testing; Animals; axion; Axon; axon regeneration; Back; base; Binding; Biocompatible; Biological; biomaterial compatibility; Biomechanics; Cadaver; Chronic; Cicatrix; Clinical; comparative; Connective Tissue; cost; density; design; Development; Device Designs; Devices; Elements; Environment; Equilibrium; Family suidae; FDA approved; Fibrin Tissue Adhesive; flexibility; functional outcomes; Geometry; Growth; Health Care Costs; Human; Implant; implantation; improved; Inflammation; Injury; Invaded; Licensing; manufacturing process; Mechanics; Medical Device; Methods; Microscope; Microscopic; Modeling; Nerve; Nerve Endings; nerve injury; Nerve Regeneration; Nerve Tissue; neurotropic; novel; Operative Surgical Procedures; Oryctolagus cuniculus; Outcome; Outcome Measure; Patients; Peripheral Nerves; Phase; Physiological; prevent; Procedures; prototype; public health relevance; Recovery; regenerative; repaired; Reporting; Research; research clinical testing; research study; Safety; Sampling; Site; stem; Surgical sutures; Techniques; Technology; Testing; Time; Tissues; tool; Training; United States; Validation; Work
