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

3D 全息制导、导航和控制 (3D GN

基本信息

批准号：
10001634
负责人：
Vikash Goel
金额：
$ 80.68万
依托单位：
CENTERLINE BIOMEDICAL, INC.
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-02-15 至 2024-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10001634
关键词：
3-Dimensional 3D Print Agreement Anatomy Aneurysm Angiography Aorta Aortic Aneurysm Arteries Augmented Reality Blood Vessels Cardiac Caregivers Clinic Clinical Clinical Research Complex Contrast Media Data Depth Perception Development Devices Disease Dose Economics Effectiveness Electromagnetics Elements Engineering Evaluation Exposure to Family suidae Feasibility Studies Feedback Fluoroscopy Focus Groups Funding Future General Hospitals Goals Health Benefit Healthcare Healthcare Systems Institutional Review Boards Intervention Investigation Label Low Dose Radiation Manufacturer Name Massachusetts Medical center Methods Modeling Modernization Monitor Neck North Carolina Notification Operative Surgical Procedures Outcome Patients Performance Phase Positioning Attribute Postoperative Complications Preparation Procedures Protocols documentation Quality of Care Questionnaires Radiation Radiation Dose Unit Recording of previous events Research Roentgen Rays Safety Scallop Small Business Innovation Research Grant Small Business Technology Transfer Research Specific qualifier value Stents Surgeon Surveys System Technology Testing Time Translations Universities Vendor Visualization base bench to bedside commercialization cost design digital experience first-in-human head mounted display health care quality hologram holographic visualization human study improved innovation migration minimally invasive mixed reality mortality multidisciplinary nephrotoxicity patient population perioperative morbidity pre-clinical prevent prototype repaired sensor three-dimensional visualization usability

项目摘要

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.

项目概要/摘要这个 SBIR 第二阶段项目将推进我们的 3D 制导、导航和控制（3D- GNC）系统通过以下方式改善血管内主动脉瘤修复（EVAR）过程中覆膜支架（SG）的部署克服 2D X 射线透视检查（“3D-GNC”）的局限性将提高安全性、有效性和安全性。更好的可视化带来的效率，特别是在不利的主动脉解剖结构中部署 SG 时，诸如短和/或有角度的着陆区等挑战，不受限制的真正 3D (360°)、无辐射 GNC。 2D 显示器将减少对患者和手术室工作人员的辐射，缩短手术时间，并实现准确的 SG 定位可减少术后并发症或需要重新干预。产品创新将扩大符合 EVAR 资格的患者群体，特别是那些病情严重的患者随着微创方法的需求和使用不断增加，主动脉解剖结构不利。在第一阶段，开发了 3D-GNC 研究原型并将其与我们的术中定位相集成系统 (IOPS)。指导子系统以数字方式将患者特定的主动脉模型增强到手术中。使用现代、独立的增强/混合现实头戴式显示器进行精确导航。实时跟踪配备传感器的电线 (IOPS-SG1 Wire) 的 3D 位置和方向 (P&O) 投影 SG 全息图与主动脉全息图进行空间配准。建议当输送系统接近动脉瘤的近端颈着陆区时进行 P&O 操作。第一阶段的结果满足特定目标的所有验收标准，包括 1) 重点实验室测试的可用性由 10 名外科医生组成的小组，2) 六个 3D 打印主动脉模型中 SG 输送系统定位的准确性复杂的解剖结构，以及 3) 3D-GNC 在我们的临床前方案中相对于氟的优势：辐射剂量和对比剂剂量（减少 100%）、手术时间（减少 56.4%）和定位精度（增加 41.5%）。在第二阶段，我们将根据第一阶段的成果开发、验证和验证 3D-GNC 系统，正在进行中用户反馈以及我们的质量管理体系 (QMS) 我们将评估 3 个领先的主动脉的可用性。医疗中心（目标 1），并通过部署来自至少 2 个制造商的 SG 来验证工作台上的准确性使用设计的受控系统组件3D打印模型（目标2）在IDE和IRB许可后，我们将。在目标 3 中进行首次人体研究，以证明使用 3D-GNC 作为辅助药物并得到证实氟是安全有效的，可以降低辐射剂量，同时获得设计最终确定的反馈。开发将符合我们的质量管理体系，为 FDA 上市前审批做好准备（目标 4）。克服荧光的局限性和改善 SG 放置将为实现全面的临床和治疗铺平道路。 EVAR 相对于高侵入性开放手术修复的经济效益将得到我们技术的商业化。其影响超出了动脉瘤疾病的范围，包括许多新兴的血管和心脏手术使更广泛的患者和护理人员受益，并在全球范围内提供更优质的医疗保健。