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

用于治疗慢性静脉功能不全的形状记忆聚合物泡沫血管闭塞装置

• 批准号: 8979042
• 负责人: Todd Landsman
• 金额: $ 19.96万
• 依托单位: SHAPE MEMORY MEDICAL INC.
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-08-25 至 2016-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8979042
• 关键词: Ablation; Accounting; Address; Adult; American; Aneurysm; Blood; Blood Vessels; Blood flow; Body Temperature; Chronic; Cicatrix; Collaborations; Collection; Contusions; Deep Vein Thrombosis; Development; Device Designs; Devices; Disclosure; Dislocations; Edema; Effectiveness; Embolism; Endothelium; Ensure; Family suidae; Fracture; Goals; Gold; Healed; Health Care Costs; Healthcare; Heart; Hemostatic function; Human; Hypertension; Imagery; In Vitro; Individual; Lead; Left; Leg; Legal patent; Life; Ligation; Liquid substance; Lower Extremity; Mechanics; Memory; Microscopy; Modeling; Monitor; Muscle Contraction; Nerve; Nerve Tissue; Odors; Operative Surgical Procedures; Outcome; Pain; Particulate; Pathway interactions; Patients; Pelvis; Perfusion; Peripheral; Phase; Physicians; Physiological; Polymers; Polyurethanes; Population; Portal vein structure; Positioning Attribute; Procedures; Property; Pruritus; Psychological Stress; Quality of life; Recurrence; Reflux; Reporting; Research; Resources; Risk; Rupture; Saphenous Vein; Sclerotherapy; Shapes; Skin; Social isolation; Spider Veins; Sterile coverings; Surgeon; Symptoms; Techniques; Technology; Texas; Therapeutic; Therapeutic Embolization; Thrombophlebitis; Time; Tissues; Ulcer; Ultrasonography; United States; Universities; Varicocele; Varicose Ulcer; Varicosity; Veins; Venous; Venous Insufficiency; Work; adverse outcome; biomaterial compatibility; blood vessel occlusion; commercialization; design; experience; healing; implantation; in vitro Model; limb amputation; migration; minimal risk; minimally invasive; open wound; operation; preclinical study; prevent; public health relevance; radiologist; success

 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.

 描述（由申请人提供）：据估计，美国有 600 万人患有慢性静脉功能不全 (CVI) 的严重症状，其中多达 500,000 人患有或将出现静脉溃疡，这会导致严重疼痛、活动受限、缺勤、心理压力以及散发出的气味可能会导致患者与社会隔离。在美国，每年与 CVI 相关的医疗费用超过 10 亿美元。英国目前的 CVI 治疗费用超过 6.5 亿美元，包括手术剥离和结扎回流静脉、硬化疗法和静脉内消融术，目前治疗 CVI 的黄金标准是静脉内消融术 (EVA)。 EVA 治疗后仍有报道称 EVA 的其他局限性是手术的复杂性、无法用于过度弯曲或短的血管以及报道的手术疼痛。该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，用于治疗与 CVI 相关的并发症。VOD 将提供快速、完全的大隐静脉闭塞，同时将装置脱位的风险降至最低。完成静脉内消融手术所需的时间和手术难度也将显着减少，以确保所提出的装置在温度下稳定。治疗区域的流速是患者通常看到的流速的四倍，当受到弯曲和压缩时，还将监测设备从治疗区域的迁移，以模拟行走和肌肉收缩期间在外周血管中看到的情况。还将进行验证研究，以确保在设备灌注过程中不会产生颗粒。这些研究将使 VOD 在体温下承受不同流速 30 分钟，所有含有任何颗粒的灌注液体将收集在收集盆中。灌注然后，液体将通过 5 µm 孔径过滤器过滤，随后通过显微镜进行分析，以确定是否符合 USP <788> 中规定的标准。最后，VOD 将由执业介入治疗师传送至大隐静脉的 PDMS 模型。放射科医生和血管外科医生使用传统的静脉内技术和超声检查，对该装置的导航性、可视化、易用性和部署以及闭塞目标血管的有效性进行评估。