Small Diameter (3-5mm), Nanofibrous Biomimetic Vascular Graft Prosthesis

描述（由申请人提供）：在这个快速通道SBIR申请中，NanoVasc （Alameda， CA）计划使用其专有和创新的静电纺丝工艺（最初在加州大学伯克利分校Song Li博士的实验室开发）来开发用于治疗冠状动脉疾病（CAD）和外周动脉疾病（PAD）的小直径血管移植物（称为纳米移植物）。NanoVasc的创新之处是开发了一种小直径血管移植物（内径3-5mm），使用一种生物可降解且具有生物活性的仿生支架。这项研究显示了血管搭桥手术领域的巨大前景，因为电纺丝纳米纤维支架的结构和形态可以被操纵成与天然细胞外基质（ECM）相似，因此为细胞迁移创造了一个更“熟悉”的环境。该公司有初步证据表明，内径1mm的纳米纤维血管移植物在体内的表现和重塑具有非常令人鼓舞的结果。本项目将重点开发小直径移植物，在体外评估其物理化学特性、生物和血液相容性以及血小板/血栓相互作用，然后在羊模型中评估其生物相容性和体内动力学、相容性/通畅性和安全性。在第一阶段，将研究聚合物选择、表面改性和机械完整性。通过给定标准的候选人将使用体外血液再循环循环进行血栓性、生物学和血液相容性测试。II期将重点研究羊双侧颈总动脉模型28天和140天的体内通畅性。对照将包括市售的4mm ePTFE血管移植物。

DESCRIPTION (provided by applicant): In this Fast Track SBIR application, NanoVasc (Alameda, CA) plans to use its proprietary and innovative electrospinning process (initially developed at U.C. Berkeley in Dr. Song Li's Lab) to develop small diameter vascular grafts (called NanoGrafts) for the treatment of Coronary Artery Disease (CAD) and Peripheral Arterial Disease (PAD). NanoVasc's innovation is the development of a small diameter vascular graft (3-5mm internal diameter) using a biomimetic scaffold that is both biodegradable and bioactive. This research shows great promise for the field of vascular bypass surgeries, as the structure and morphology of electrospun, nanofibrous scaffolds can be manipulated to resemble that of natural extracellular matrix (ECM), therefore creating a more "familiar" environment for the cells to migrate into. The company has preliminary evidence showing the performance and remodeling of a 1mm internal diameter, nanofibrous vascular grafts in vivo with very encouraging results. This project will focus on developing small diameter grafts, evaluating their physico-chemical properties, biological and hemo-compatibility and platelet/thrombus interactions in vitro, and then evaluating their biocompatibility and in vivo dynamics, compatibility/patency and safety in a sheep model. In Phase I, polymer selection, surface modification, and mechanical integrity will be investigated. The candidates that pass the given criteria will then be tested for thrombogenicity, biological and hemo-compatibility using an in vitro blood recirculation loop. Phase II will focus on the in vivo patency in a sheep bilateral common carotid artery model for 28 and 140 days. Controls will include commercially available, 4mm ePTFE vascular grafts.