Ultrasound-guided, Robotically Steerable Guidewire for Endovascular Interventions

用于血管内介入治疗的超声引导机器人可操纵导丝

• 批准号: 10155555
• 负责人: JAYDEV P. DESAI
• 金额: $ 69.62万
• 依托单位: GEORGIA INSTITUTE OF TECHNOLOGY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-04-15 至 2023-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10155555
• 关键词: 3-Dimensional; 3D Print; Address; Adopted; Adult; Algorithms; American; Animal Model; Animal Testing; Animals; Atherosclerosis; Blood Vessels; Bypass; Cadaver; Calcium; Caliber; Cardiology; Cessation of life; Chronic; Chronic Disease; Clinical; Collagen; Communities; Consumption; Custom; Deposition; Devices; Distal; Elements; Exposure to; Failure; Feedback; Fibrin; Fluoroscopy; Freedom; Goals; Health Care Costs; Heart failure; Human; Image; Injury; Intervention; Interventional radiology; Ischemia; Lateral; Lead; Length; Lesion; Letters; Limb structure; Maps; Mechanics; Medical; Modeling; Motion; Operative Surgical Procedures; Oral cavity; Organ; Patient-Focused Outcomes; Patients; Physicians; Procedures; Property; Pulsatile Flow; Radiation; Radiation exposure; Risk; Robotics; Running; Side; Stents; Stroke; Structure; Surface; System; Tendon structure; Testing; Time; Tissues; Transducers; Treatment outcome; Ultrasonic Transducer; Ultrasonography; calcification; clinically translatable; cost; design; flexibility; hazard; healing; image guided; image guided intervention; improved; innovation; limb amputation; new technology; notch protein; novel; oral lesion; prototype; real-time images; robotic system; spine bone structure; success; vibration

The burden of atherosclerotic vascular disease is immense among adult Americans, contributing to about 800,000 deaths per year. Chronic total occlusions (CTO) are the riskiest, most challenging, and least successful of these vascular lesions to treat with traditional stenting or endovascular devices. Procedural complexity and failure with CTO's are attributed to the lesion structure, which includes a fibrous calcific plaque on the proximal entry side of the lesion, and an irregular micro-lumen spanning its length. Passing a guidewire across this lesion is challenging, as the lateral view provided by 2D fluoroscopic imaging does not directly identify the “mouth”/entry to the lumen. The flexible tips of the guidewires bend due to multiple-impacts with stiff lesions, increasing the technical challenge with each additional attempt. Even successful procedures are time-consuming, involve chance, require prolonged patient and physician exposure to radiation and use excessive amounts of contrast. This clinical challenge is well recognized in the community. Breaking the calcium with mechanical vibrations or drilling was adopted by several, but the need for a large bore tip to house such mechanical components makes it applicable only in larger vessels. In addition, the debris resulting from such an approach carries the risk of ischemia or stroke in the distal organs. Since endovascular approaches are increasingly utilized over surgical bypass of CTO's, there is an urgent need to develop new technologies to meet this critical need! Thus, the overall goal of this project is to develop a novel steerable guidewire with a miniature forward- viewing ultrasound (US) transducer to enable real-time image-guided CTO traversal. We will address three specific aims – Sp. Aim 1: Design and develop a robotically steerable, 0.014” diameter guidewire (0.355 mm) system that can accommodate a .350 mm x .350 mm US transducer at its tip and can be steered with image feedback from the transducer. Sp. Aim 2: Design and build a forward-looking transducer for the robotically steerable guidewire and an algorithm to reconstruct an image of the encountered occlusion. Sp. Aim 3: To iteratively optimize the US-steerable guidewire design using 3D printed patient-specific models of CTO's, realistic human cadaver limbs with CTO, and a live animal model of CTO's. This project is innovative on several fronts. It represents the first use of intravascular steerable robotic guidewire capable of forward looking US imaging and image-guided navigation through vasculature and occluded vessels. The ability to steer, visualize and navigate the guidewire is highly novel and will eventually result in improvement of clinical workflow and patient treatment outcomes. This highly interdisciplinary project combines expertise in medical robotics, US imaging, pulsatile flow models and image-guided interventions in animal models, interventional cardiology, and interventional radiology. The US-guided, intravascular steerable robotic system will have significant societal impact through improved patient outcomes, reduced radiation exposure for the physician and the patient, reduced rate of procedural failures, and lower healthcare costs.

动脉粥样硬化性血管疾病给美国成年人带来了巨大的负担，导致约 每年有 80 万人死亡。慢性完全闭塞（CTO）是最危险、最具挑战性和最不成功的 使用传统支架或血管内装置治疗这些血管病变。程序复杂性和 CTO 的失败归因于病变结构，其中包括近端的纤维钙化斑块 病变的入口侧，以及横跨其长度的不规则微腔。将导丝穿过该病变 具有挑战性，因为 2D 荧光镜成像提供的侧视图不能直接识别 “嘴”/管腔的入口。导丝的柔性尖端由于对僵硬病变的多次冲击而弯曲， 每一次额外的尝试都会增加技术挑战。即使成功的手术也很耗时， 涉及机会，需要患者和医生长时间暴露于辐射并使用过量的 对比。这一临床挑战得到了社区的广泛认可。用机械破钙 振动或钻孔已被一些公司采用，但需要大孔径尖端来容纳这种机械 组件使其仅适用于较大的容器。此外，这种方法产生的碎片 具有远端器官缺血或中风的风险。由于血管内方法的使用越来越多 由于 CTO 的外科搭桥手术，迫切需要开发新技术来满足这一迫切需求！ 因此，该项目的总体目标是开发一种具有微型前向的新型可操纵导丝。 查看超声 (US) 传感器，以实现实时图像引导的 CTO 遍历。我们将解决三个问题 具体目标 – Sp。目标 1：设计和开发机器人可操纵、直径 0.014 英寸的导丝（0.355 毫米） 系统可在其尖端容纳 0.350 mm x 0.350 mm US 传感器，并可通过图像进行控制 来自传感器的反馈。 Sp。目标 2：为机器人设计并构建具有前瞻性的传感器 可操纵导丝和重建所遇到的闭塞图像的算法。 Sp。目标 3： 使用 CTO 的 3D 打印患者特定模型迭代优化 US 可操纵导丝设计， 带有 CTO 的逼真人体尸体四肢，以及 CTO 的活体动物模型。该项目在多个方面都有创新 战线。它代表了首次使用能够前瞻性美国的血管内可操纵机器人导丝 通过脉管系统和闭塞血管的成像和图像引导导航。驾驶能力、可视化能力 和导航导丝是非常新颖的，最终将改善临床工作流程和 患者的治疗结果。这个高度跨学科的项目结合了美国医疗机器人技术的专业知识 动物模型中的成像、脉动血流模型和图像引导干预、介入心脏病学和 介入放射学。美国引导的血管内可操纵机器人系统将具有重大的社会价值 通过改善患者治疗效果、减少医生和患者的辐射暴露来产生影响， 降低程序失败率并降低医疗费用。