EVVS: Endoscopic Venous Valve System

EVVS：内窥镜静脉瓣膜系统

• 批准号: 9408948
• 负责人: Janet Galtes
• 金额: $ 42.2万
• 依托单位: VENARUM MEDICAL, LLC
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-07-01 至 2018-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9408948
• 关键词: Acute; Affect; American; Amputation; Anatomy; Angiography; Animals; Ankle; Area; Autopsy; Benchmarking; Blood; Blood Cells; Blood Circulation; Blood coagulation; Blood flow; Caliber; Chronic; Clinical; Complication; Consensus; Coronary; Deep Vein Thrombosis; Device Designs; Devices; Disease; Edema; Embolism; Engineering; Evaluation; Extravasation; Failure; Family suidae; Fatigue; Flushing; Functional disorder; Fund Raising; Funding; Health; Human; Implant; In Vitro; Individual; Industry; Knee; Leg; Legal patent; Liquid substance; Lung; Measures; Medical; Medical Device Designs; Methodology; Methods; Modeling; Obstruction; Outcome; Patients; Performance; Phase; Physiological; Polymers; Positioning Attribute; Postoperative Period; Procedures; Process; Progressive Disease; Prosthesis; Prosthesis Design; Radial; Recording of previous events; Reflux; Resistance; Risk; Science; Secure; Site; Skin; Stents; Structure; Structure of jugular vein; Structure of popliteal vein; Structure of superficial vein; Sudden Death; Surface; System; Testing; Thrombus; Tissues; Ulcer; Varicose Ulcer; Veins; Venous; Venous Insufficiency; Venous Pressure level; base; biomaterial compatibility; cooking; cost; deep vein; design; effective therapy; engineering design; evaluation/testing; experience; flexibility; fluid flow; implantation; improved; in vitro testing; in vivo; migration; nitinol; novel; operation; persistent symptom; pressure; prototype; scaffold; three-dimensional modeling; valve replacement

Project Summary / Abstract Venarum Medical, LLC (Venarum), proposes to validate the “Endoscopic Venous Valve System” (EVVS), a novel patent-pending valve-replacement solution for serious complications of chronic venous disease (CVD) such as chronic venous insufficiency (CVI) and specifically, dysfunctional venous valves. This device is based on the principle that a nitinol stent-like scaffold embedded in a biocompatible, thrombus-resistant polymer with a similar polymeric inner-valve comprised of flexible valve leaflets, placed at the site of valve failure (i.e. dysfunctional valve) will provide improved forward flow, and reduce risk of edema, ulcers, and amputation. Chronic venous insufficiency (CVI), often caused by venous valve dysfunction, is a costly long-term and progressive disease that afflicts approximately 2.5 million Americans per year. Associated venous valve reflux leads to blood clotting and/or fluid leakage into skin and other tissues in the legs and ankles. Resulting health issues are severe and costly to treat. CVI can manifest itself in both superficial and deep veins, but deep veins are the most crucial to circulation. Current clinical solutions treat only the symptoms of CVI but not the underlying physiological causes, so effective treatment of CVI in deep veins is an unmet clinical need. The past few decades have seen dramatic improvements in understanding the causes and course of CVI, and vast progress in the use of nitinol stents and polymer valves. Armed with “lessons learned” and a unique design approach, Venarum will develop an endovascular prosthetic venous valve comprising a stent-like Nitinol frame with an integral novel polymer leaflet valve securely attached to its inner structure. Venarum expects to create a valve that operates with low opening and closing pressure differentials, provides adequate forward flow, minimizes reflux and thrombus formation, and is suitable for percutaneous endovascular delivery. Further, the valve prosthesis will be designed for precise deployment, canalization of the vein lumen, and non- migration post-deployment. Venarum will employ a proven Nitinol prosthesis design team using detailed performance requirements to develop the proposed valve system design. An advanced prototype frame and valve will be developed using an iterative approach which refines candidate designs using 2D & 3D modeling, numerical strain analysis, rapid prototyping and precision in vitro testing. Resulting prototypes will then be evaluated and refined for fluid flow performance, endoscopic delivery, and durability. Bench test evaluations including those for radial strength, crimping, forward flow, leak/reflux, flow stagnation, burst pressure, tear resistance, and fatigue will be conducted. Hemocompatibility, related in vitro tests, and an in vivo acute animal study will be the culmination of Phase I. Venarum’s proposed prosthetic venous valve could greatly alleviate complications related to CVI, produce dramatic improvement in the technical and medical understanding of CVI problems, and may one day enable an affordable treatment option for CVI that does not exist today.

项目概要/摘要 Venarum Medical, LLC (Venarum) 提议验证“内窥镜静脉瓣膜系统”(EVVS) 正在申请专利的新型瓣膜置换解决方案，用于治疗慢性静脉疾病 (CVD) 的严重并发症 例如慢性静脉功能不全 (CVI)，特别是静脉瓣膜功能障碍。 其原理是将镍钛合金支架状支架嵌入生物相容性抗血栓聚合物中 具有类似的由柔性瓣叶组成的聚合物内瓣膜，放置在瓣膜失效的部位（即， 功能失调的瓣膜）将改善前向血流，并降低水肿、溃疡和截肢的风险。 慢性静脉功能不全（CVI）通常由静脉瓣膜功能障碍引起，是一种代价高昂的长期疾病 每年影响约 250 万美国人的进行性疾病 相关静脉瓣膜。 反流导致血液凝固和/或液体渗漏到腿部和脚踝的皮肤和其他组织中。 CVI 的健康问题非常严重且治疗成本高昂，可在浅静脉和深静脉中表现出来，但在深静脉中则更是如此。 静脉对于血液循环最重要，目前的临床解决方案只能治疗 CVI 的症状，但不能治疗其他疾病。 潜在的生理原因，因此有效治疗深静脉 CVI 是过去未得到满足的临床需求。 几十年来，人们对 CVI 的原因和过程的了解有了显着的进步，并且 凭借“经验教训”和独特的设计，镍钛诺支架和聚合物瓣膜的使用取得了进展。 Venarum 将开发一种由类似支架的镍钛合金组成的血管内人工静脉瓣膜 Venarum 的框架具有牢固地固定在其内部结构上的一体式新型聚合物瓣膜。 创建一种在低开启和关闭压差下运行的阀门，提供足够的前向 血流，最大限度地减少反流和血栓形成，适合经皮血管内输送。 此外，瓣膜假体将被设计用于精确部署、静脉腔的疏通和非 部署后迁移。 Venarum 将聘请经过验证的镍钛合金假体设计团队，根据详细的性能要求来 开发拟议的阀门系统设计将使用开发先进的原型框架和阀门。 一种迭代方法，使用 2D 和 3D 建模、数值应变分析、 然后将评估和完善最终的原型并进行快速原型设计和精确的体外测试。 流体流动性能、内窥镜输送和耐久性的台架测试评估，包括径向测试。 强度、卷曲、前向流动、泄漏/回流、流动停滞、爆破压力、抗撕裂性和疲劳将 将进行血液相容性、相关体外测试和体内急性动物研究。 第一阶段的高潮。Venarum 提出的人工静脉瓣膜可以大大减轻并发症 与 CVI 相关，显着提高对 CVI 问题的技术和医学理解， 有一天可能会为 CVI 提供一种目前尚不存在的负担得起的治疗选择。