Shape Memory Polymer Foam Vascular Occlusion Device for the Treatment of Chronic Venous Insufficiency

 描述（由申请人提供）：据估计，美国有600万人患有严重的慢性静脉功能不全（CVI）症状。这些人中有多达50万人患有或将患上静脉溃疡，这会导致剧烈疼痛、行动不便、缺勤、心理压力，并散发出可能导致患者社会孤立的气味。每年与CVI相关的医疗费用在美国超过10亿美元，在英国超过6.5亿美元。目前CVI的治疗方法包括回流静脉的手术剥离和结扎、硬化疗法和静脉内消融。目前治疗CVI的金标准是静脉内消融（伊娃）。然而，伊娃治疗后复发率仍高达32%。伊娃的其他局限性是手术的复杂性，无法用于过度迂曲或短血管，以及患者报告的手术疼痛。 拟议项目概述了形状记忆聚合物（SMP）泡沫血管闭塞装置（VOD）的开发，以治疗与CVI相关的并发症。VOD将提供快速、完全的大隐静脉闭塞，器械脱位、血管破裂以及周围组织和神经损伤的风险最小。完成静脉内消融手术所需的时间和手术难度也将显著降低。 将进行实验室验证研究，以确保申报器械在流速为患者通常流速四倍的治疗区域保持稳定。在屈曲和压缩时，也将监测器械从治疗区域的移位，以模拟在截肢和肌肉收缩期间在外周血管中观察到的情况。还将进行验证研究，以确保在器械灌注期间不会产生颗粒。这些研究将使VOD在体温下以各种流速运行30分钟，并将含有任何颗粒的所有灌注液收集在收集盆中。然后将灌注液通过5 µ m微孔过滤器过滤，随后通过显微镜进行分析，以确定是否符合USP规定的标准。<788>最后，VOD将由执业介入放射科医生和血管外科医生使用常规静脉内技术和超声检查输送到大隐静脉的PDMS模型。将评价器械的可导航性、可视化、易用性和展开性以及闭塞靶血管的有效性。

 DESCRIPTION (provided by applicant): It's estimated that 6 million people in the United States suffer from severe symptoms of chronic venous insufficiency (CVI). Up to 500,000 of these individuals have or will develop venous ulcers, which cause severe pain, limited mobility, absence from work, psychological stress, and exude an odor that can lead to social isolation of the patient. The annual healthcare cost associated with CVI is more than $1 billion in the United States and more than $650 million in the UK. Current treatments of CVI include surgical stripping and ligation of refluxing veins, sclerotherapy, and endovenous ablation. The current gold standard for treating CVI is endovenous ablation (EVA). However, recurrence rates as high as 32% have still been reported after EVA treatment. Other limitations of EVA are the complexity of the procedure, inability to be used in excessively tortuous or short vessels, and the procedural pain reported by patients. The proposed project outlines the development of a shape memory polymer (SMP) foam vascular occlusion device (VOD) to treat complications associated with CVI. The VOD will provide rapid, complete occlusion of the great saphenous vein with minimal risk of device dislocation, vessel rupture, and damage to surrounding tissue and nerves. The time required, and procedural difficulty, to complete endovenous ablation procedures will also be significantly reduced. Benchtop verification studies will be performed to ensure the proposed devices are stable at the treatment region under flow rates four times greater than what is typically seen in patients. Device migration from the treatment region will also be monitored when subjected to flexion and compression to mimic the conditions that would be seen in the peripheral vessels during ambulation and muscle contraction. Verification studies will also be performed to ensure no particulates are created during perfusion of the device. These studies will subject the VOD to various flow rates at body temperature for 30 minutes, and all perfused fluid containing any particulates will be collected in a collection basin The perfused fluid will then be strained through a 5µm pore filter that will be subsequently analyzed via microscopy to determine compliance with the criteria dictated in USP <788>. Finally, the VOD will be delivered to a PDMS model of the great saphenous vein by a practicing interventional radiologist and vascular surgeon using conventional endovenous techniques and ultrasonography. The device will be evaluated for navigability, visualization, ease of use and deployment, and effectiveness in occluding the target vessel.