Bi-layered Diametrically Patterned Nanofibrous Dural Substitutes for Enhanced Dur

描述（由申请人提供）：NanoNerve正在开发一种新型直径图案纳米纤维硬脑膜替代品，用于神经外科手术后的硬脑膜快速再生。仅在美国，每年就有22.5万例神经外科手术需要修补硬脑膜，以防止渗漏、感染和神经损伤。目前可用的硬脑膜替代品包括异种胶原基质和永久性合成装置。异种胶原基质具有机械强度低、可缝合性低、成本高、疾病传播风险大等显著缺点。永久性合成装置也有主要缺点，包括硬脑膜再生困难，植入过程中需要广泛缝合和较高的泄漏率。该项目的总体目标是FDA 510(K)批准和高度通用的直径图案纳米纤维硬脑膜替代品的商业化。NanoNerve正在利用其正在申请专利的静电纺丝技术，以直径图案纳米纤维快速再生硬脑膜组织，从缺陷的整个外围到中心。NanoNerve的合成生物可吸收纳米纤维硬脑膜替代物的超薄外形和高机械强度将使其成为第一种能够缝合和无缝合植入的合成硬脑膜替代物。这个第一阶段的项目将评估直径图案纳米纤维硬脑膜替代品的生物学性能，并在急性犬硬脑膜成形术模型中与两种领先的商业产品进行比较。I期里程碑的成功完成将使II期的生物相容性、稳定性和长期体内植入研究成为可能。在完成II期里程碑后，NanoNerve将向FDA提交人体临床试验IDE申请。

DESCRIPTION (provided by applicant): NanoNerve is developing a novel diametrically patterned nanofibrous dural substitute for rapid dura mater regeneration following neurosurgical procedures. In the US alone, 225,000 neurosurgical procedures are performed annually that require patching of the dura mater to prevent leakage, infection and neural damage. Currently available dural substitutes include xenogenic collagen matrices and permanent synthetic devices. Xenogenic collagen matrices have significant disadvantages including low mechanical strength, low suturability, high cost and disease transmission risks. The permanent synthetic devices also suffer from major disadvantages including resistance to dura mater regeneration, need for extensive suturing during implantation and higher leakage rates. The overall goal of the project is FDA 510(K) clearance and commercialization of a highly versatile diametrically patterned nanofibrous dural substitute. NanoNerve is utilizing its patent pending electrospinning technology to diametrically pattern nanofibers for rapidly regenerating dural tissue from the entire periphery of the defect toward the center. NanoNerve's synthetic bioresorbable nanofibrous dural substitute's ultra-thin profile and high mechanical strength will enable it to become the first synthetic dural substitute capable of sutured and suture-free implantation. This Phase I project will assess the biological performance of the diametrically patterned nanofibrous dural substitute and compare against two leading commercial products in an acute canine duraplasty model. Successful completion of Phase I milestones will enable biocompatibility, stability and long-term in vivo implantation studies in Phase II. Upon achievement of Phase II milestones, NanoNerve will file an FDA IDE application for human clinical testing. PUBLIC HEALTH RELEVANCE: Over 225,000 neurosurgical procedures are performed annually that require grafting of the dura mater to prevent fluid leakage, infection and neural tissue damage. Currently available dural substitutes have major limitations including incomplete dural repair, low mechanical strength and high leakage rate complications. This phase I study will enable development of a strong, versatile and diametrically patterned nanofibrous dural substitute for rapid and effective dura mater regeneration.