硅橡胶和聚氨酯制作的结肠囊管性能测试

背景：鉴于结直肠穿孔及吻合口漏的治疗上传统手术方法时间长、创伤大、费用高，故急需设计出一种医疗器械对这两种疾病实施微创、安全、有效的一期修复。 目的：设计一种能经肛门进出，能对结直肠穿孔及结直肠吻合口漏进行一期修复的医疗器械，并对其各项性能进行客观检测。 方法：采用医用硅橡胶、医用聚氨酯按设计方案制作出结肠液囊管样品，然后对样品外套囊的柔韧度、内管及外套囊的变形压力值、液囊管的漏气压力值进行检测比较，评估结肠液囊管临床使用的可行性、安全性。 结果与结论：采用医用硅橡胶与医用聚氨酯制作出的结肠液囊管外套囊变形压力值分别为(30.42±0.46)，(30.73±0.29) kPa，内管变形压力值分别为(5.96±0.22) kPa及> 100 kPa，液囊管漏气压力值分别为(59.23±1.25)，(60.01±1.45) kPa，医用硅橡胶制作出的结肠液囊管内管硬度不够，容易内突导致管腔狭窄闭合，外套囊变形压力值稍小，但差异无显著性意义(P=0.088)，液囊管漏气压力值无明显差别(P=0.213)。提示采用医用聚氨酯制作的结肠液囊管结构简单、性能优良、操作方便、安全可靠。

Performance testing of colon sac duct prepared with silicone rubber and polyurethane

BACKGROUND:It is urgent in clinic to design a kind of medical equipment that is microinvasive, safe and effective for treatment of colorectal perforation and anastomotic leakage. OBJECTIVE:To design a kind of medical equipment that can be put into the colon through the anus to aid the treatment of colorectal perforation and anastomotic leakage, and then to test the performance so as to verify its safety and reliability for clinical application. METHODS:The colon sac duct was made of medical silicon rubber and medical polyurethane. Then, the outer capsule flexibility, deformation pressure of inner ducts and outer capsule, colon sac duct leak pressure were tested so as to assess the feasibility and safety of the duct in clinical application. RESULTS AND CONCLUSION:The outer capsule deformation pressure of the colon sac duct was (30.42±0.46) kPa for medical silicon rubber and (30.73±0.29) kPa for medical polyurethane. The inner duct deformation pressure values were (5.96±0.22) kPa and > 100 kPa, respectively. The colon sac duct leakage gas pressure was (59.23±1.25) kPa and (60.01±1.45) kPa, respectively. The rigidity of the colon sac duct was not better enough, thus easily leading to the stricture and closure of inner tube cavity. The deformation pressure of the outer capsule was somewhat lower, but there was no significant difference (P=0.088), leakage gas pressure of sac duct was no significant difference (P=0.213). The colon sac duct made of polyurethane possessed simple structure and excellent performance: easy to operation, safety and reliability.