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化纳米纤维硬脑膜替代物，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225，000例神经外科手术需要修补硬脑膜以防止泄漏，感染和神经损伤。目前可用的硬脑膜替代物包括异种胶原基质和永久性合成装置。异种胶原基质具有显著的缺点，包括低机械强度、低可缝合性、高成本和疾病传播风险。永久性合成装置还具有主要缺点，包括硬脑膜再生阻力、植入期间需要广泛的缝合和较高的泄漏率。该项目的总体目标是获得FDA 510（K）批准，并将一种高度通用的直径图案化纳米纤维硬脑膜替代物商业化。NanoNerve正在利用其正在申请专利的静电纺丝技术，以直径方向图案化纳米纤维，用于从缺损的整个周边向中心快速再生硬脑膜组织。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个能够缝合和无缝合植入的合成硬脑膜替代物。该I期项目将评估直径图案化纳米纤维硬脑膜替代物的生物学性能，并在急性犬硬脑膜成形术模型中与两种主要商业产品进行比较。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。在实现第二阶段的里程碑后，NanoNerve将提交FDA IDE申请进行人体临床试验。

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.