Endovascular Orifice Detection (EOrD) Device for in situ Fenestration of Abdominal Aortic Aneurysm

项目摘要 腹主动脉瘤（AAA）是一种局部扩张的主动脉，如果不及时治疗，可能会继续下去， 导致90%的死亡率这是美国第15大死亡原因 每年报告的年死亡人数超过15，000人的州。当动脉瘤达到最大 直径标准（大于5.0 - 5.5 cm），临床医生将采用开放手术或血管内介入 修复（腹主动脉瘤腔内修复术）。对于复杂AAA病例，微创开孔型腹主动脉瘤腔内修复术（FEVAR）优于 然而，在高风险开放手术中，开孔支架移植物延伸通过内脏动脉（肾动脉、上级动脉 肠系膜动脉和腹腔动脉），并且在展开后必须再血管化， 预制的目前，市场上只有一种FDA批准的开孔型移植物，即Cook Zenith 移植物，需要额外的成像制造与6 - 8周的交货时间，成本高达3倍以上 并且在将导丝穿过腹主动脉瘤腔内修复术覆膜支架时可能具有技术挑战性 开孔的孔口。本项目的目标是开发一种用于血管内治疗的医疗器械。 孔检测（EOrD），其将定位内脏动脉并执行原位开窗术。这个装置可以 然后应用于AAA、升动脉瘤和创伤性主动脉损伤的用例。 进行了初步的体外实验以确定是否可以检测到内脏动脉 通过螯合的羊血和覆膜支架材料使用红外（IR）波。放大的传感器阵列 使用光电晶体管沿着模拟数字转换器来检测反射的红外波。 当传感器阵列扫过内脏动脉的开口时，收集不同的信号响应， 确认可行性。在检测到内脏动脉的开口后，我们计划使用 低功率激光器或机械穿刺机构，其同时插入导丝以展开 桥接支架。 我们最初的EOrD原型与建议的方法将通过导管鞘输送， 使用真实的体外AAA体模测试了瓣口检测、穿刺和导丝插入， 尸体我们临床专家的持续反馈将改进设计迭代， 能够可靠和可重复地进行覆膜支架原位开窗术以治疗主动脉瘤的原型 动脉瘤通过我们的新设备，我们可以改善患者的医疗保健并降低相关的总体成本。 AAA修复

Project Summary Abdominal aortic aneurysm (AAA) is a localized dilatation of the aorta and if left untreated may go on to rupture which is associated with a 90% mortality rate. This is the 15th leading cause of death in the United States with more than 15,000 annual deaths reported annually. When an aneurysm reaches the maximum diameter criteria (greater than 5.0 – 5.5 cm), clinicians will intervene with either open surgery or endovascular repair (EVAR). For complex AAA cases, a minimally invasive fenestrated EVAR (FEVAR) is preferred over high-risk open surgery, however, fenestrated stent-grafts extend past the visceral arteries (renal, superior mesenteric artery and celiac artery) and must be revascularized after deployment requiring the stent-graft to be prefabricated. Currently, there is only one FDA approved fenestrated graft on the market, the Cook Zenith Graft, that requires additional imaging for fabrication with a 6 - 8 week delivery time, costs up to 3 times more than traditional EVAR stent-grafts and can be technically challenging when passing guidewires through the orifices of the fenestrations. The objective of this project is to develop a medical device for endovascular orifice detection (EOrD) which will both locate visceral arteries and perform in situ fenestration. This device can then be applied in the use cases of AAA, ascending aneurysms, and traumatic aortic injury. Preliminary in vitro experiments were performed to determine whether visceral arteries could be detected through chelated sheep blood and stent-graft material using infrared (IR) waves. A scaled-up sensor array was built using phototransistors along with an analog to digital converter to detect the reflected IR waves. Distinct signal responses were collected while sweeping the sensor array over the orifice of the visceral artery, confirming feasibility. After an orifice of the visceral artery is detected, we plan to create a fenestration using a low-powered laser or mechanical puncturing mechanism that simultaneously inserts a guidewire to deploy the bridging stents. Our initial EOrD prototype with the proposed approach will be delivered through a catheter sheath and tested for orifice detection, puncture, and guidewire insertion using realistic in vitro AAA phantoms and cadavers. Continuous feedback from our clinical experts will improve design iterations to develop a final prototype that is able to reliably and reproducibly perform in situ fenestration of stent-grafts to treat aortic aneurysms. With our novel device, we can improve patient healthcare and reduce overall costs associated with AAA repair.