Vascular Sealing Device

描述(由申请人提供)： 全球每年有超过700万例插管手术，血管通路闭合部位的并发症发生率为10%-20%。常规的抗凝药物给药会进一步延迟血管的封闭。手动按压一直是经皮冠状动脉介入治疗后闭合的标准护理，但它需要4-12小时的卧床休息，大量的医务人员时间，以及相关的较高成本。最近，有几种封堵器被引入，但并发症发生率仍然很高，仍然不建议立即下床。 落基山生物系统公司建议开发一种新技术(VeniSeal)来解决血管关闭问题。VeniSeal使用一种专有的密封化合物，通过感应耦合激活，以实现鞘道和血管穿孔的立即和安全关闭。封闭过程可以在有血液和超额止血压力的情况下进行。 在第一阶段，我们将建立一个原型VeniSeal激活装置，线圈，并改进粘合剂。该装置和粘合剂将在体外实验室测试中用于密封血管开口，以评估这种方法在封闭人体伤口方面的潜力。在第二阶段，将设计一种简单的喷雾器，并在动物身上进行测试。

DESCRIPTION (provided by applicant): Over 7 million catheterization procedures are performed worldwide each year, with a 10-20% complication rate in closing the vascular access site. The routine administration of anticoagulant medication can further delay sealing the vessel. Manual compression has been the standard of care for closure after percutaneous coronary interventions, but it requires 4-12 hours of bed rest, significant medical staff time, and associated higher costs. Recently, several closure devices have been introduced, but complication rates are still high and immediate ambulation is still not recommended. Rocky Mountain Biosystems, Inc., proposes developing a new technology (VeniSeal) to address the vascular closure problem. VeniSeal which uses a proprietary sealing compound that is activated using inductive coupling to achieve immediate and secure closure of both the sheath tract and vessel puncture. The sealing process can be done in the presence of blood and excess hemostatic pressure. In Phase I, we will build a prototype VeniSeal activation device, coil, and improve the adhesive compound. The device and adhesive will be used to seal vascular openings in ex vivo laboratory tests to evaluate the potential of this method to seal wounds in humans. In Phase II, a simple applicator will be designed and tested in animals.