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

该小型企业创新研究（SBIR）II期项目的更广泛影响/商业潜力将是开发一种用于慢性静脉功能不全（CVI）瓣膜置换治疗的医疗器械。目前，没有明确的治疗方案来解决疾病的根本原因，瓣膜反流，这使得数百万患者患有慢性静脉溃疡，皮肤增厚和疼痛数年至数十年。当推向市场时，所提出的新型人工瓣膜和输送系统将提供上级当前治疗选择的可行的治愈性治疗，并减轻与现有人工瓣膜相关的并发症，例如血栓形成和瓣膜功能不全。拟议的产品将减少与CVI相关的大量医疗保健支出，如伤口护理、感染住院和相关的二次手术。由于这种瓣膜的植入不需要现有技术的复杂或侵入性手术干预，因此其使用也将避免与开放式手术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。SBIR二期项目旨在开发一种新颖、可靠、可销售的人工瓣膜和输送系统，用于治疗静脉功能不全。在第一阶段，为超过实验室和动物基准的设备创建了设计。II期拟定开发通过证明瓣膜最大限度减少血栓形成的能力以及大规模生产的能力，改进了更广泛展开的设计。第二阶段的目标是：1）开发和生产下一代瓣膜用于体外和动物试验; 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）完成设计的生物相容性试验，以确保其适用于人体试验; 5）确定器械的可制造性。这些步骤将为未来的临床试验提供基础，以证明该设备在人体中的安全性和有效性。该奖项反映了NSF的法定使命，并被认为值得通过使用基金会的知识价值和更广泛的影响审查标准进行评估来支持。

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.