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

• 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
• 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

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.

项目摘要/摘要 这个SBIR II期项目将推进我们3D指导，导航和控制的商业化（3D- GNC）在血管内主动脉瘤修复期间改善支架移植（SG）部署的系统 克服2D X射线荧光镜（“ Fluoro”）的局限性。 3D-GNC将提高安全性，有效性，并且 效率是更好的可视化效率，尤其是在敌对主动脉解剖结构中部署SG时 较短和/或倾斜着陆区等挑战。 True 3D（360°），不受限制的无辐射GNC 通过2D显示，将减少对患者和 /或员工的辐射，减少程序时间，并启用准确 SG定位导致术后并发症的较少或需要重新干预。转换这个 对产品的创新将扩大符合EVAR的患者人群，尤其是那些高度的人 随着最小侵入性方法的需求和利用率不断上升，主动脉解剖结构不利。 在第一阶段，开发了一个3D-GNC研究原型，并与我们的术中定位进行了整合 系统（IOPS）。指导子系统数字化将患者特异性主动脉模型扩大到手术 使用现代，独立的增强/混合现实头安装的显示器进行场地。准确导航 实时的轨道，配备传感器的电线（IOPS-SG1线）的3D位置和方向（P＆O） 用主动脉全息图投射在空间注册中的SG全息图。我们的全息控制面板 当交付系统接近动脉瘤的近端颈部着陆区时，建议P＆O操纵。 第一阶段的结果符合特定目标的所有接受标准。 10个外科医生组，2）SG递送系统定位的精度 复杂的解剖学和3）在我们的临床前协议中相对于荧光：辐射剂量和 对比剂量（减少100％），程序时间（减少56.4％）和定向准确性（增加41.5％）。 在第二阶段，我们将基于I期结果开发，验证和验证3D-GNC系统 用户反馈和我们的质量管理系统（QMS）。我们将评估3个领先主动脉的可用性 医疗中心（AIM 1）并通过部署至少2个制造商的SG来验证替补席上的准确性 3D打印模型使用设计的受控系统组件（AIM 2）。 IDE和IRB清除后，我们将 在AIM 3中进行第一项人类研究，以证明使用3D-GNC作为辅助并确认 Fluoro是安全有效的，可以降低辐射剂量，同时获得设计最终化的反馈。全部 开发将符合我们的QMS，以准备FDA前市场清算（AIM 4）。 克服Fluoro和改善SG放置的局限性将为实现完整的临床和 EVAR的经济利益比高度侵入性的开放手术修复。我们技术的商业化将 除了动脉瘤疾病以外的影响是否包括许多新兴的血管和心脏程序 受益于广泛的患者，护理人员，并在全球范围内提供更好质量的医疗保健。