Nash J E, Evans D G
Kensey Nash Corporation (KNC), Exton, Pennsylvania, USA.
Herz. 1999 Dec;24(8):597-606. doi: 10.1007/BF03044483.
The Angio-Seal hemostatic puncture closure device is the culmination of development efforts dating from 1986. Development was driven to solve problems of delivering a multi-piece bioabsorbable puncture closure assembly through an introducer, the precise placement of the device in the vessel, the mastery of molding tiny absorbable polymer components, the manufacture of collagen hemostatic sponges having strong tear strength, and the testing of very large samples to establish safety and efficacy. Improvements included in the new 6F device to improve deployment reliability are also discussed.
血管封堵止血穿刺闭合装置是自1986年以来研发工作的结晶。研发的驱动力在于解决通过导管将多部件生物可吸收穿刺闭合组件输送到位、在血管中精确放置该装置、掌握微小可吸收聚合物部件的成型技术、制造具有强大抗撕裂强度的胶原蛋白止血海绵以及对大量样本进行测试以确定安全性和有效性等问题。文中还讨论了新型6F装置中为提高展开可靠性而进行的改进。
