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Vascular Sealing Device

血管封闭装置

基本信息

批准号：
6836827
负责人：
Kevin Marchitto
金额：
$ 12.54万
依托单位：
ROCKY MOUNTAIN BIOSYSTEMS, INC.
依托单位国家：
美国
项目类别：
财政年份：
2004
资助国家：
美国
起止时间：
2004-08-01 至 2005-01-31
项目状态：
已结题

项目摘要

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.

描述（由申请人提供）：全世界每年进行超过700万次导管插入手术，在闭合血管通路部位时的并发症发生率为10-20%。抗凝药物的常规给药可进一步延迟凝闭血管。人工压迫一直是经皮冠状动脉介入治疗后闭合的标准护理，但它需要卧床休息4-12小时，医务人员需要大量时间，相关成本较高。最近，已经引入了几种闭合装置，但并发症发生率仍然很高，仍然不建议立即进行Amberment。落基山生物系统公司，建议开发一种新技术（VeniSeal）来解决血管闭合问题。VeniSeal使用专有密封化合物，通过感应耦合激活，实现鞘管通道和血管穿刺的立即和安全闭合。密封过程可以在存在血液和过度止血压力的情况下完成。在第一阶段，我们将建立一个原型VeniSeal激活装置，线圈，并改善粘合剂化合物。该器械和粘合剂将用于在离体实验室试验中密封血管开口，以评价该方法密封人体伤口的潜力。在第二阶段，将设计一个简单的施用器，并在动物身上进行测试。