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

这个小型企业创新研究(SBIR)第二阶段项目的更广泛的影响/商业潜力将是开发一种用于瓣膜置换治疗慢性静脉功能不全(CVI)的医疗设备。目前，尚无明确的治疗方案来解决这种疾病的根本原因--瓣膜返流，这会使数百万患者患有慢性静脉溃疡、皮肤增厚和数年至数十年的疼痛。当建议的新型人工瓣膜和输送系统投放市场时，将提供一种可行的治疗方法，优于目前的治疗方案，并减少与现有瓣膜假体相关的并发症，如血栓形成和瓣膜功能不全。拟议的产品将减少与CVI相关的大量医疗支出，如伤口护理、感染住院和相关的二次手术。由于植入这种瓣膜不需要现有技术的复杂或侵入性外科干预，它的使用还将避免与开放手术程序和康复护理相关的费用。这项创新的商业化有望使CVI患者受益，同时显著降低成本。这项SBIR第二阶段项目旨在开发一种新的、可靠的、有市场价值的人工瓣膜和输送系统，用于治疗功能不全的静脉。在第一阶段，设计了一种超过实验室和动物基准的装置。第二阶段提出的开发改进了更广泛部署的设计，展示了阀门最大限度减少血栓形成的能力以及规模化生产的能力。第二阶段的目标是：1)开发和生产用于体外和动物试验的下一代瓣膜；2)在体外研究中比较瓣膜设计的安全性；3)在慢性动物研究中证明领先设计的安全性和有效性；4)对设计进行完整的生物兼容性测试，以确保其适合人体试验；以及5)建立设备的可制造性。这些步骤将为未来的临床试验奠定基础，以证明该设备在人体上的安全性和有效性。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project will be to develop a medical device for valve replacement treatment of chronic insufficiency of the veins (CVI). Currently, no definitive treatment option exists to address the underlying cause of the disease, valvular reflux, which leaves millions of patients with chronic venous ulcers, skin thickening, and pain for years to decades. When brought to market, the proposed novel prosthetic valve and delivery system will provide a viable curative therapy superior to current treatment options and mitigating complications associated with existing valve prostheses, such as thrombosis and valve incompetence. The proposed product will curtail substantial health care expenditures associated with CVI, such as wound care, hospitalizations for infections, and associated secondary procedures. Because implantation of this valve does not require the complex or invasive surgical interventions of existing technologies, its use also will avoid expenses associated with open surgical procedures and rehabilitative care. The commercialization of this innovation is expected to benefit CVI patients, while significantly reducing costs.This SBIR Phase II project aims to develop a novel, reliable, and marketable prosthetic valve and delivery system for the treatment of incompetent veins. In Phase I, a design was created for a device that exceeded laboratory and animal benchmarks. Phase II proposed development improves the design for broader deployment by demonstrating the the valve's ability to minimize thrombosis as well as the capability to be produced at scale. Phase II objectives are to: 1) Develop and produce the next generation valve for in vitro and animal testing; 2) Compare safety of valve designs in an in vitro study; 3) Demonstrate the safety and efficacy of the leading design in a chronic animal study; 4) Complete biocompatibility testing on the design to ensure it is appropriate for human testing; and 5) Establish manufacturability of the device. These steps will provide the foundation for future clinical trials to demonstrate safety and efficacy of the device in humans.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.