Testing of a sclerosing and embolizing gel for venous disease

静脉曲张是慢性静脉疾病的一种表现，其特征是在功能不全的静脉中发生血液反流，导致静脉扩张。由于大隐静脉（GSV）瓣膜衰竭，下肢常出现静脉曲张。除了审美问题、水肿和疼痛，静脉曲张还会导致严重的并发症，如腿部溃疡。在美国，最近对变异患病率的估计从男性的15%到女性的28%不等。在性腺静脉中也观察到静脉曲张，导致女性严重腹痛，男性睾丸疼痛和不育。胃食管静脉曲张常见于肝硬化门静脉高压患者，可导致危及生命的出血。治疗静脉曲张提出了不同的方法。机械技术，如结扎、剥离、用机械装置闭塞用于防止反流，而化学消融术用硬化剂或热消融术用激光或射频探针旨在破坏静脉壁。这些疗法通常联合使用，结果可能不理想，导致症状复发和重做手术，导致成本增加和生活质量下降。我们在CRCHUM开发了一种由壳聚糖（一种生物可吸收凝胶，结合硬化剂（十四烷基硫酸钠））制成的硬化和栓塞凝胶并获得专利。这种凝胶在x光和超声波下也可见，可以在成像引导下安全分娩。该凝胶被授权给Cook Medical (USA)，一家世界领先的介入放射医疗设备开发公司。我们建议与Cook Medical和chitolytic（一家供应医药级壳聚糖的加拿大公司）合作，开发一种专门适用于静脉硬化治疗的配方，并在猪静脉模型中进行测试。

Varicose veins are a part of a spectrum of manifestations of chronic vein disorders that arecharacterized by the occurence of blood reflux in incompetent veins leading to vein dilatation.Varicose veins are often observed in lower legs due valve failure of the great saphenous vein(GSV). Beside aesthetic concern, edema and pain, varicosities can lead to seriouscomplications such as leg ulcers. The recent estimates of the prevalence of varicosities in theUnited States range from 15% among men to 28% in women. Varicose veins are alsoobserved in gonadal veins causing severe abdominal pain in women and testicular pain andinfertility in men. Gastro-esophageal varices veins are often observed in cirrhosis patient withportal hypertension leading to life threatening bleeding.Different techniques were proposed to treat varicose veins. Mechanical techniques such asligation, stripping, occlusion with mechanical devices are used to prevent reflux whereaschemical ablation with sclerosant or thermal ablation with laser or radiofrequency probes aimto destroy the wall of the vein. These therapies are often used in combination and the resultscan be suboptimal leading to recurrence of symptoms and redo procedures leading toincrease cost and deterioration of the quality of life.We have developed and patented a sclerosing and embolizing gel at CRCHUM made ofchitosan a bio-absorbable gel combined with a sclerosant agent (Sodium Tetradecyl Sulfate).This gel is also visible under X-ray and ultrasound which allows safe delivery under imagingguidance.The gel was licensed to Cook Medical (USA), a world leader company in the development ofmedical device for interventional radiology. We propose in partnership with Cook Medical andChitolytic, a canadian company supplying pharmaceutical grade chitosan, to develop aformulation specifically adapted for venous sclerotherapy and test it in a porcine venousmodel.