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

用于腹主动脉瘤原位开窗的血管内孔口检测 (EOrD) 装置

• 批准号: 10612075
• 负责人: Mohammad Hamed Eslami
• 金额: $ 22.97万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-20 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10612075
• 关键词: Abdominal Aortic Aneurysm; Address; Anatomy; Aneurysm; Angiography; Annual Reports; Aorta; Aortic Aneurysm; Aortic Injury; Arteries; Blood; Blood flow; Cadaver; Catheters; Cause of Death; Cessation of life; Chest; Clinical; Complex; Consumption; Custom; Detection; Development; Devices; Diameter; Dilatation - action; FDA approved; Feedback; Geometry; Healthcare; Image; In Situ; In Vitro; Kidney; Lasers; Left; Liquid substance; Marketing; Mechanics; Medical Device; Methods; Neck; Operative Surgical Procedures; Organ Transplantation; Patients; Perfusion; Physiologic pulse; Population; Procedures; Psychological reinforcement; Pump; Puncture procedure; Radiation; Recovery; Reporting; Reproducibility; Risk; Rupture; Sheep; Signal Transduction; Stents; Superior mesenteric artery structure; Techniques; Testing; Time; United States; Vascularization; Visceral; analog; celiac artery; chelation; comorbidity; cooking; cost; design; digital; experimental study; fabrication; high risk; iliac artery; improved; innovation; iterative design; mechanical load; meetings; minimally invasive; mortality; novel; phantom model; prototype; renal artery; repaired; research and development; response; scale up; seal; sensor; success

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.

项目摘要 腹主动脉瘤（AAA）是主动脉的局部扩张，如果未治疗，可能会继续进行 破裂与90％的死亡率有关。这是曼联的第15个主要死因 每年有15,000多人死亡的州报告。当动脉瘤达到最大值时 直径标准（大于5.0 - 5.5厘米），临床医生将干预开放手术或血管内 维修（EVAR）。对于复杂的AAA案例，优先于最低侵入性的EVAR（FEVAR） 然而，高风险的开放手术，长座的支架移植物延伸过内脏动脉（肾脏，上级 肠系膜动脉和腹腔动脉），部署后必须进行血运重建，要求支架移植 预制。目前，市场上只有一个FDA批准的Fenrectratsed Graft，Cook Zenith 嫁接，需要在6-8周的交货时间内进行额外的制造成像，费用高达3倍 比传统的evar支架移植物，在通过指南通过的技术挑战 欲望的孔口。该项目的目的是开发用于血管内的医疗设备 孔口检测（EORD）将既定位内脏动脉又进行原位进行。该设备可以 然后将其应用于AAA的用例中，升高动脉瘤和创伤性主动脉损伤。 进行了初步的体外实验，以确定是否可以检测到内脏动脉 通过螯合的绵羊血和支架移植物材料使用红外（IR）波。扩展的传感器阵列 是使用光晶体管以及与数字转换器的类似物一起构建的，以检测反射的IR波。 在将传感器阵列扫到内脏动脉孔时，收集了不同的信号响应， 确认可行性。在检测到内脏动脉孔口后，我们计划使用 低功率的激光或机械刺穿机制，该机制仅插入导线以部署 桥接支架。 我们最初采用建议方法的eord原型将通过导管鞘运输，然后 使用现实的体外AAA幻影和 尸体。我们临床专家的持续反馈将改善设计迭代，以开发最终 能够可靠和可重复执行的原位固定术的原型，以治疗主动脉 动脉瘤。借助我们的新设备，我们可以改善患者医疗保健并降低相关的总体成本 进行AAA维修。