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

基本信息

批准号：
10392386
负责人：
JAYDEV P. DESAI
金额：
$ 67.67万
依托单位：
GEORGIA INSTITUTE OF TECHNOLOGY
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-04-15 至 2025-03-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10392386
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 ultrasound vibration

项目摘要

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.

成年美国人的动脉粥样硬化血管疾病的伯宁巨大每年800,000人死亡。慢性全部阻塞（CTO）是最风险，最挑战，最不成功的在这些血管病变中，可以用传统的支架或血管内装置治疗。程序复杂性和 CTO失败归因于病变结构，该病变结构包括近端的纤维钙化斑块病变的入口侧，不规则的微隆横向其长度。通过该病变经过导丝是挑战，因为2D荧光影像成像提供的横向视图并未直接识别 “嘴”/进入管腔。指南的灵活尖端由于多重损伤而弯曲，每次尝试增加技术挑战。即使成功的程序也很耗时，涉及机会，需要长时间的患者和身体暴露于辐射，并使用过多的对比。这种临床挑战在社区中得到了广泛认可。用机械打破钙几个人采用了振动或钻孔，但是需要大钻头来容纳这种机械组件使其仅适用于较大的视频。另外，通过这种方法产生的碎屑远端器官有缺血或中风的风险。由于血管内方法越来越多地使用通过外科手术的CTO旁路，迫切需要开发新技术以满足这种关键需求！这是这个项目的总体目标是用微型前锋开发一个新颖的可训练导丝。查看超声（US）换能器以实现实时图像引导的CTO遍历。我们将解决三个特定目的 - sp。 AIM 1：设计和开发一个机器人可通道的，直径为0.014英寸的指南（0.355 mm）可以容纳.350毫米x .350毫米美国传感器的系统，并且可以用图像蒸传感器的反馈。 sp。 AIM 2：为机器人设计并构建一个前瞻性传感器可通话的导线和一种算法，以重建遇到的遮挡图像。 sp。目标3：到使用3D打印的CTO特定于患者的模型，以迭代性优化美国驱动的指南设计现实的人类尸体与CTO和CTO的现场动物模型。这个项目在几个方面具有创新性正面。它代表了血管内通话的机器人指南的首次使用，能够向前寻找我们成像和图像引导通过脉管系统和阻塞血管的导航。转向，可视化的能力并且导航导线是高度新颖的，最终将改善临床工作流程和患者治疗结果。这个高度跨学科的项目结合了美国医学机器人技术的专业知识，美国动物模型中的成像，脉动流量模型和图像引导的干预措施，介入心脏病学和介入放射学。美国引导的，血管内可探可的机器人系统将具有重要的社交通过改善患者预后的影响，身体和患者的辐射暴露减少，降低了程序失败的速度和降低医疗保健成本。