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

项目摘要 腹主动脉瘤(Aaa)是一种局限性的主动脉扩张，如果不治疗，可能会继续 破裂与90%的死亡率有关。这是美国第15大死因。 每年报告死亡人数超过15,000人的州。当动脉瘤达到最大程度时 直径标准(大于5.0-5.5厘米)，临床医生将采用开放手术或血管内介入 修复(EVAR)。对于复杂的AAA病例，微创开窗EVAR(FEVAR)优于 然而，高风险的开放手术中，带窗支架移植物延伸到内脏动脉(上肾动脉)之外。 肠系膜动脉和腹腔动脉)，必须在部署后重新血运重建，要求支架移植物 预制的。目前，市场上只有一种FDA批准的开窗移植物，即Cook Zenith 移植物需要额外的成像来制造，交付时间为6-8周，成本高达3倍 与传统的EVAR支架相比，在将导丝穿过 开窗的孔口。本项目的目标是开发一种血管内治疗的医疗器械 开口检测(EOrD)，既可以定位内脏动脉，也可以进行原位开窗。该设备可以 然后应用于腹主动脉瘤、升主动脉瘤和创伤性主动脉损伤的使用案例。 进行了初步的体外实验，以确定是否可以检测到内脏动脉 通过使用红外线(IR)的螯合羊血和支架移植材料。放大的传感器阵列 它使用光电晶体管和模数转换器来检测反射的红外线。 当传感器阵列扫过内脏动脉的开口时收集到不同的信号响应， 确认可行性。在检测到内脏动脉的开口后，我们计划使用 低功率激光或机械穿孔机构，同时插入导丝以展开 桥接支架。 我们最初提出的方法的EOrD原型将通过导管护套和 使用真实的体外AAA模体和 身体。我们临床专家的持续反馈将改进设计迭代，以开发最终的 一种能够可靠和可重复性地进行支架原位开窗治疗主动脉的原型 动脉瘤。有了我们的新设备，我们可以改善患者的医疗保健并降低相关的总体成本 带AAA级修复。

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.