3D Holographic Guidance, Navigation, and Control (3D GN&C) for Endovascular Aortic Repair (EVAR)

项目摘要/摘要 这个SBIR二期项目将推进我们的3D制导、导航和控制(3D- GNC)系统通过以下方式改进主动脉瘤腔内修复术(EVAR)中支架-移植物(SG)的部署 克服二维X射线透视(“透视”)的局限性。3D-GNC将提高安全性、有效性和 更好的可视化带来的效率，特别是在敌对的主动脉解剖中部署SGS时， 挑战，如短和/或倾斜的着陆区。真正的3D(360°)、不受限制的无辐射GNC 通过2D显示将减少对患者和/或工作人员的辐射，减少手术时间，并实现准确 SG定位可减少术后并发症或需要再次介入治疗。将此转换为 产品的创新将扩大符合EVAR条件的患者群体，特别是那些高度 随着微创入路的需求和使用率持续上升，对主动脉解剖不利。 在第一阶段，3D-GNC研究原型被开发并与我们的术中定位相结合 系统(IOPS)。引导子系统将特定于患者的主动脉模型数字化地增强到外科手术中 使用现代的、独立的增强/混合现实头盔显示器。准确导航 实时跟踪配备传感器的焊线(IOPS-SG1焊线)的3D位置和方向(P&O) 将SG全息图与主动脉全息图进行空间配准。我们的全息控制面板 提示P&O在输送系统接近动脉瘤近端颈部着陆区时进行操作。 阶段I结果满足特定目标的所有验收标准，1)Focus在台架测试中的可用性 10名外科医生组成的小组，2)在6个3D打印的主动脉模型中精确定位SG输送系统， 复杂的解剖结构，以及3)3D-GNC在我们的临床前方案中相对于荧光的好处：辐射剂量和 对比剂剂量(减少100%)、操作时间(减少56.4%)和定位准确性(增加41.5%)。 在第二阶段，我们将根据第一阶段的结果，继续开发、验证和验证3D-GNC系统 用户反馈和我们的质量管理体系(QMS)。我们将评估3个领先的大动脉的可用性 医疗中心(目标1)，并通过部署来自至少2家制造商的SGS在工作台上验证准确性 使用设计的受控系统组件的3D打印模型(目标2)。在IDE和IRB通过后，我们将 在目标3中进行第一次人类研究，以演示3D-GNC作为附件使用并得到以下证实 氟是安全和有效的，可以降低辐射剂量，同时获得设计定稿的反馈。全 开发将符合我们的质量管理体系，为FDA上市前的批准(目标4)做准备。 克服透视的局限性，改进SG的放置方式，将为实现充分的临床和 EVAR的经济效益优于高侵入性开放手术修复。我们技术的商业化将 除了动脉瘤疾病外，还包括许多新出现的血管和心脏手术 使更多的患者和护理人员受益，并在全球范围内提供更高质量的医疗保健。

Project Summary/Abstract This SBIR Phase II project will advance the commercialization of our 3D guidance, navigation, and control (3D- GNC) system to improve stent-graft (SG) deployment during endovascular aortic aneurysm repair (EVAR) by overcoming limitations of 2D x-ray fluoroscopy (“fluoro”). 3D-GNC will increase safety, effectiveness, and efficiency as a result of better visualization, particularly when deploying SGs within hostile aortic anatomy, with challenges such as short and/or angled landing zones. True 3D (360°), radiation-free GNC that is not limited by a 2D display will decrease radiation to patients and OR staff, reduce procedure time, and enable accurate SG positioning leading to fewer postoperative complications or need for re-intervention. Converting this innovation to a product will expand the patient population eligible for EVAR, particularly those with highly unfavorable aortic anatomy, as the demand and utilization of the minimally-invasive approach continues to rise. In Phase I, a 3D-GNC research prototype was developed and integrated with our Intra-Operative Positioning System (IOPS). The Guidance subsystem digitally augments the patient-specific aortic model to the surgical field using a modern, self-contained augmented/mixed reality head mounted display. Navigation accurately tracks in real-time the 3D position and orientation (P&O) of a sensor-equipped wire (IOPS-SG1 Wire) for projecting a SG hologram in spatial registration with the aorta hologram. Our holographic Control panel suggests P&O maneuvers as the delivery system approaches the aneurysm's proximal neck landing zone. Phase I results met all acceptance criteria for Specific Aims in terms of 1) usability in bench testing by a focus group of 10 surgeons, 2) accuracy for SG delivery system positioning in six 3D-printed aortic models with complex anatomy, and 3) benefits of 3D-GNC in our preclinical protocol relative to fluoro: radiation dose and contrast dose (100% decrease), procedure time (56.4% decrease), and orientation accuracy (41.5% increase). In Phase II, we will develop, verify and validate the 3D-GNC system based on Phase I outcomes, on-going user feedback, and our quality management system (QMS). We will evaluate usability at 3 leading aortic medical centers (Aim 1) and verify accuracy on the bench by deploying SGs from at least 2 manufacturers in 3D-printed models using designed controlled system components (Aim 2). After IDE and IRB clearance, we will conduct a first-in-human study in Aim 3 to demonstrate that use of 3D-GNC as an adjunct to and confirmed by fluoro is safe and effective and can lower radiation dose, while obtaining feedback for design finalization. All development will be in compliance with our QMS, toward preparation for FDA premarket clearance (Aim 4). Overcoming limitations of fluoro and improving SG placement will pave the way to realizing the full clinical and economic benefits of EVAR over highly invasive open surgical repair. Commercialization of our technology will have implications beyond aneurysmal disease to include many emerging vascular and cardiac procedures to benefit a broader population of patients, caregivers, and enable delivery of better quality healthcare globally.