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

该小型企业创新研究（SBIR）I期项目的更广泛影响/商业潜力是确定外周动脉疾病患者新血管定向生长器械的可行性。 该设备是合成的，但被设计为一个模板，以鼓励患者自己的细胞形成新的组织。新组织形成后，该装置被身体吸收，留下新的血管。 每年，美国约有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，但有些患者必须依赖其他选择，包括合成血管假体。目前可用的合成血管假体是一个众所周知的穷人的选择，高达60%的失败在3年内。拟议的项目将提供对支持血管修复先进治疗的新技术的重要理解。 这项技术有机会帮助那些由于现有器械性能不佳而继续需要额外手术修复的患者。 该技术可以在全球超过40亿美元的外科血管修复市场中占据很大份额。拟议的项目探讨了旨在引导患者体内新血管生长的血管模板的机械和生物属性，并将其与目前治疗外周动脉疾病的标准进行比较。 目前可用的合成血管假体具有较差的长期通畅性，这归因于缺乏融合的内皮组织形成。 这些器械几乎没有创新，未能充分解决导致通畅性差的根本原因。 为了成功，模板首先需要像常规血管假体一样承受机械力。 这些包括爆破压力和缝线固位强度。 此外，模板的顺应性应与自体血管相当，以减少植入后的不良反应。 我们将针对这些值测试模板并进行必要的修改。 然后将使用猪的动物研究来比较我们的模板与金标准，即由天然血管制成的假体。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的人造血管指南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.