Testing of a sclerosing and embolizing gel for venous disease

静脉疾病硬化和栓塞凝胶的测试

• 批准号: 549711-2020
• 负责人: Soulez, Gilles
• 金额: $ 12.7万
• 依托单位: Université de Montréal
• 依托单位国家: 加拿大
• 项目类别: Collaborative Health Research Projects
• 财政年份: 2020
• 资助国家: 加拿大
• 起止时间: 2020-01-01 至 2021-12-31
• 项目状态: 已结题
• 来源: https://www.nserc-crsng.gc.ca/ase-oro/Details-Detailles_eng.asp?id=699049
• 关键词: Testing; sclerosing; embolizing; gel; venous

Varicose veins are a part of a spectrum of manifestations of chronic vein disorders that are characterized 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 serious complications such as leg ulcers. The recent estimates of the prevalence of varicosities in the United States range from 15% among men to 28% in women. Varicose veins are also observed in gonadal veins causing severe abdominal pain in women and testicular pain and infertility in men. Gastro-esophageal varices veins are often observed in cirrhosis patient with portal hypertension leading to life threatening bleeding. Different techniques were proposed to treat varicose veins. Mechanical techniques such as ligation, stripping, occlusion with mechanical devices are used to prevent reflux whereas chemical ablation with sclerosant or thermal ablation with laser or radiofrequency probes aim to destroy the wall of the vein. These therapies are often used in combination and the results can be suboptimal leading to recurrence of symptoms and redo procedures leading to increase cost and deterioration of the quality of life. We have developed and patented a sclerosing and embolizing gel at CRCHUM made of chitosan 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 imaging guidance. The gel was licensed to Cook Medical (USA), a world leader company in the development of medical device for interventional radiology. We propose in partnership with Cook Medical and Chitolytic, a canadian company supplying pharmaceutical grade chitosan, to develop a formulation specifically adapted for venous sclerotherapy and test it in a porcine venous model.

静脉曲张是慢性静脉疾病表现的一部分 其特征是出现血液反流在无能的静脉中导致静脉扩张。 由于大隐静脉的瓣膜故障，通常在小腿中观察到静脉曲张 （GSV）。除了审美关注，水肿和疼痛，静脉曲张还可以导致严重 腿部溃疡等并发症。最近对静脉曲张的流行率的估计值 美国的男性中的15％到女性的28％不等。静脉曲张也是 在性腺静脉中观察到，导致女性严重的腹痛和睾丸疼痛和 男人不孕。在肝硬化患者患者中，经常观察到胃食管静脉曲张 门户高血压导致生命威胁出血。 提出了不同的技术来治疗静脉曲张。机械技术，例如 连接，剥离，用机械设备的阻塞用于防止反流 用激光或射频探针用硬化剂或热消融的化学消融 摧毁静脉的墙。这些疗法通常用于组合和结果 可以是次优的导致症状和重做程序的复发，导致 增加成本和生活质量的恶化。 我们已经开发了并在由Crchum制成的硬化和栓塞凝胶专利 壳聚糖可生物吸收的凝胶与硬化剂（四烷基硫酸钠）结合使用。 该凝胶在X射线和超声波下也可见，可以在成像下安全地交付 指导。 凝胶获得了库克医疗（美国）的许可，美国是一家世界领导人的公司 介入放射学的医疗设备。我们与Cook Medical合作提议 Chitolosolytic是一家提供药品级壳聚糖的加拿大公司，以开发 专门适用于静脉硬化疗法的配方，并在猪静脉 模型。