Testing of a sclerosing and embolizing gel for venous disease

静脉曲张是一系列慢性静脉疾病的表现之一，其特征是在功能不全的静脉中发生血液回流，导致静脉扩张。静脉曲张通常发生在小腿，由于大隐静脉（GSV）瓣膜衰竭。除了美观、水肿和疼痛，静脉曲张还可导致严重的并发症，如腿部溃疡。美国静脉曲张患病率的最新估计范围为男性15%至女性28%。在性腺静脉中也可以观察到静脉曲张，导致女性严重腹痛，男性睾丸疼痛和不育。胃食管静脉曲张是肝硬化门静脉高压症患者常见的并发症，常导致危及生命的出血，因此提出了不同的治疗方法。机械技术如结扎、剥脱、用机械装置闭塞用于防止反流，而硬化剂化学消融或激光或射频探针热消融旨在破坏静脉壁。这些疗法经常联合使用，结果可能不理想，导致症状复发和重复手术，导致费用增加和生活质量下降。我们在CRCHUM开发了一种硬化和栓塞凝胶，并获得专利，该凝胶由壳聚糖制成，一种生物可吸收凝胶与硬化剂结合（十四烷基硫酸钠）。这种凝胶在X射线和超声下也是可见的，可以在成像引导下安全输送。这种凝胶被许可给Cook Medical（美国），一家世界领先的介入放射学医疗器械开发公司。我们建议与Cook Medical和Chitolytic（一家提供药用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疗法的配方，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.