SBIR Phase I: Venous Valve Prosthesis as a Cure for Chronic Venous Insufficiency

这个小型企业创新研究(SBIR)第一阶段项目的更广泛影响/商业潜力是开发一种急需的新型假体瓣膜，将为数百万患有慢性静脉功能不全(CVI)的美国患者提供潜在的治疗选择。随着年龄的增长，腿部静脉中的瓣膜功能开始变差。这使得血液在脚踝由于重力而积聚，导致脚部疼痛/肿胀，皮肤变色，最终导致脚踝开放性伤口。由于市场上没有批准的静脉瓣膜，目前的治疗包括姑息性选择，如伤口护理和皮肤移植。对于无法治愈的静脉淤积性溃疡，这些治疗方法可能会让每位患者花费数万美元。这项拟议的技术将用于治疗CVI，同时减少与先前尝试进行瓣膜置换相关的并发症，包括血栓形成和瓣膜破裂。所描述的方法利用了一种微创方法，避免了昂贵的支出，并在第一年的治疗中提供了高达40%的护理成本降低。拟议的项目旨在开发一种新的人工瓣膜技术，通过瞄准疾病的根本原因来治疗静脉功能不全。为了在商业化的道路上成功地取得进展，有必要在试验台上和长期的动物试验中验证这样的技术。这些步骤为未来的临床试验和最终在更广泛的人群中使用奠定了基础。他们的目标是制造设备，在实验台上比较迭代，并在动物身上验证这项技术。我们期待选择一个迭代，并获得成功的动物结果。拟议的项目将允许进一步验证所述方法的安全性和功能，并在商业化道路上取得进展。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is the development of a much-needed novel prosthetic valve that will provide a potential treatment option for the millions of U.S. patients suffering from chronic venous insufficiency (CVI). As people age, valves in the veins of their legs begin to function poorly. This allows blood to build up in the ankles due to gravity, leading to pain/swelling of the feet, skin discoloration, and ultimately open wounds by the ankles. As there is no approved venous valve on the market, current treatment consists of palliative options such as wound care and skin grafts. These treatments can cost tens of thousands of dollars per patient for non-healing venous stasis ulcers. The proposed technology will work to treat CVI while mitigating complications associated with prior attempts at valve prostheses, including formation of blood clots and valve breakdown. The approach described leverages a minimally invasive approach, averting costly expenditure and offering an up to 40% reduction in the cost of care in the first year of treatment. The proposed project aims to develop a novel prosthetic valve technology to treat incompetent veins by targeting the underlying cause of the disease. In order to successfully progress on the path to commercialization, it is necessary to validate technologies such as this on the bench and in long-term animal trials. These steps provide the foundation for future clinical trials and ultimately use in the broader population. The objectives are to build the device, compare iterations on the bench, and validate the technology in animals. We anticipate selecting an iteration and having successful animal results. The proposed project will allow for further validation of safety and function of the described approach and progress on the path to commercialization.