SBIR Phase I: Development of device intended to direct growth of new blood vessels within a patient for treatment of cardiovascular diseases

这项小企业创新研究（SBIR）一期项目的更广泛影响/商业潜力是确定外周动脉疾病患者定向新血管生长装置的可行性。该装置是人工合成的，但被设计为一个模板，以鼓励病人自己的细胞形成新的组织。在新组织形成后，该装置被身体吸收，留下新的血管。每年，美国大约有140万人需要动脉假体来治疗包括心血管疾病、外周动脉疾病和糖尿病在内的疾病。虽然许多患者能够使用自己身体的血管，但有些人必须依赖其他选择，包括合成血管假体。目前可用的合成血管假体是一个非常糟糕的选择，高达60%的人在3年内失效。拟议的项目将为支持血管修复的先进治疗的新技术提供重要的理解。这项技术有机会帮助那些由于现有设备性能不佳而继续需要额外手术修复的患者。这项技术可以占据外科血管修复市场的很大份额，该市场在全球范围内超过40亿美元。拟议的项目探索血管模板的机械和生物学特性，旨在指导患者体内新血管的生长，并将其与当前治疗外周动脉疾病的标准进行比较。目前可用的人工血管假体由于缺乏融合的内皮组织形成，其长期通畅性较差。这些设备经历了很少的创新，未能充分解决导致缺乏透明度的根本原因。为了成功，模板首先需要像常规血管假体一样承受机械力。这些指标包括破裂压力和缝线保持强度。此外，模板的顺应性应与天然血管相当，以减少植入后的不良反应。我们将测试模板中的这些值，并进行必要的修改。然后在猪身上进行动物研究，将我们的模板与金标准（一种由天然血管制成的假体）进行比较。动物研究将使我们能够回答有关细胞浸润和组织组织的关键问题。我们将使用FDA关于血管假体的指导文件作为我们研究的指南，以确保其相关性。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to determine the feasibility of a device for directed growth of a new blood vessel in patients with peripheral artery disease. The device is synthetic but is designed as a template to encourage a patient's own cells to form new tissue. After new tissue is formed, the device is absorbed by the body leaving a new blood vessel. Each year, approximately 1.4 million people in the United States require an arterial prosthesis to treat conditions of diseases including cardiovascular disease, peripheral artery disease, and diabetes. While many patients are able to use vessels from their own body, some must rely on other options including synthetic vascular prostheses. Currently available synthetic vascular prostheses are a notoriously poor option with up to 60% failing within 3 years. The proposed project will provide significant understanding of a novel technology that supports advanced treatments of vascular repair. This technology has the opportunity to help patients who continue to require additional surgical repair due to the poor performance of existing devices. This technology can capture a large share of the market for surgical vascular repair, which is over $4B worldwide.The proposed project explores the mechanical and biological attributes of a vascular template intended to direct the growth of new blood vessels within a patient and compares them with current standards for treatment of peripheral artery disease. Currently available synthetic vascular prosthesis have poor long term patency, which is attributed to the lack of confluent endothelial tissue formation. These devices have undergone little innovation and fail to adequately address the root cause leading to poor patency. In order to succeed, the template will need to first withstand the mechanical forces as a regular vascular prosthesis. These include burst pressure, and suture retention strength. In addition, the compliance of the template should be comparable to native blood vessels in order to decrease adverse effects after implantation. We will test our template for these values and make the necessary modifications. An animal study in pigs will then be used to compare our templates to the gold standard, a prosthesis made from native vessel. The animal study will allow us to answer critical questions about the cellular infiltration and tissue organization. We will use an FDA guidance document for vascular prosthesis as a guide for our studies to insure their relevance.