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

小直径（3-5mm）、纳米纤维仿生血管移植假体

• 批准号: 7930557
• 负责人: Craig Hashi
• 金额: $ 88.39万
• 依托单位: NANOVASC, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-14 至 2012-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7930557
• 关键词: Acute; Adhesions; Affect; American; Amines; Animals; Bilateral; Binding; Biocompatible; Biodegradation; Biological; Biological Assay; Biomimetics; Blood; Blood Platelets; Blood Vessel Prosthesis; Blood Vessels; Body Weight decreased; Bypass; Caliber; Carotid Arteries; Cells; Certification; Characteristics; Chemicals; Chromogenic Substrates; Chronic; Clinical; Common carotid artery; Coronary Arteriosclerosis; Deposition; Development; Dimensions; Disease; Elderly; Electrons; Embolism; Ensure; Environment; Esthetics; Ethylene Oxide; Evaluation; Exhibits; Extracellular Matrix; Fiber; Generations; Glycolates; Goals; Government; Guidelines; Healthcare Systems; Hirudin; Hirudins; Histology; Human; Hydrogen Peroxide; IACUC; Immune; Immunohistochemistry; Implant; In Vitro; Label; Lasers; Length; Life; Local Lymph Node Assay; Measures; Mechanics; Mediating; Medical Device; Methods; Microscopy; Modality; Modeling; Modification; Monitor; Morphology; Muscle Rigidity; Operative Surgical Procedures; Outcome; Patients; Peptides; Performance; Peripheral arterial disease; Permeability; Persons; Phase; Play; Polymers; Porosity; Procedures; Process; Property; Prosthesis; Proteins; Protocols documentation; Pyrogens; Quality of life; Radial; Radio; Relative (related person); Reproducibility; Research; Role; Rotation; Safety; Saline; Sample Size; Sampling; Scanning; Sheep; Side; Small Business Innovation Research Grant; Smooth Muscle; Societies; Spectrum Analysis; Speed; Staining method; Stains; Steam; Sterilization; Structure; Surface; Surgical sutures; Technology; Tensile Strength; Testing; Text; Thick; Thrombin; Thrombosis; Thrombus; Toxic effect; United States; Variant; Vascular Graft; Visual; Water; Weight; base; biomaterial compatibility; cell assembly; chemical property; covalent bond; cytotoxicity; design; digital; economic impact; genotoxicity; implantation; improved; in vitro Model; in vitro testing; in vivo; innovation; irritation; manufacturing scale-up; meetings; nanofiber; nanometer; particle; phase 1 study; physical property; pressure; prototype; public health relevance; research and development; research study; response; scaffold; success; tissue regeneration; voltage

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.

描述（由申请人提供）：在此快速通道SBIR申请中，NanoVasc（阿拉米达，CA）计划使用其专有和创新的静电纺丝工艺（最初在U.C. Song Li博士实验室的Berkeley）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NanoGrafts）。NanoVasc的创新是使用生物可降解和生物活性的仿生支架开发小直径血管移植物（3- 5 mm内径）。这项研究为血管旁路手术领域带来了巨大的希望，因为静电纺丝纳米纤维支架的结构和形态可以被操纵成类似于天然细胞外基质（ECM）的结构和形态，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，1 mm内径的纳米纤维血管移植物在体内的性能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，评价其理化性能、生物学和血液相容性以及体外血小板/血栓相互作用，然后在绵羊模型中评价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。然后，使用体外血液再循环回路对通过给定标准的候选物进行促凝性、生物学和血液相容性测试。II期将重点关注绵羊双侧颈总动脉模型中28天和140天的体内通畅性。对照品将包括市售的4 mm ePTFE血管移植物。