Magnetic Navigated Image Overlay for Vascular Access - MNIO-VA

用于血管通路的磁导航图像叠加 - MNIO-VA

• 批准号: 7393524
• 负责人: Bradley Barth Keller
• 金额: $ 14.73万
• 依托单位: BLUE BELT TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-02-01 至 2009-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7393524
• 关键词: Adult; Air; Arteries; Award; Blood Vessels; Blood flow; Caliber; Cardiac; Catheters; Cessation of life; Characteristics; Chest; Child; Clinical Trials; Color; Complication; Condition; Critical Illness; Depth; Education; Effectiveness; Esthesia; Evaluation; Faculty; Hematologic Agents; Hemodialysis; Hemorrhage; Hypotension; Image; In Vitro; Infant; Intervention; Intravenous infusion procedures; Learning; Liquid substance; Logistics; Lung; Magnetism; Mechanics; Medical; Movement; Names; Needles; Patients; Pediatric Hospitals; Phase; Population; Procedures; Rate; Simulate; Skin; Solutions; Speed; Stress; Surface; Swelling; System; Tactile; Technology; Testing; Time; Training; Trauma; Ultrasonography; Vascular System; Veins; Venous; Vision; aortic valve; fetal; improved; insight; interest; magnetic field; novel; prenatal; prenatal intervention; programs; prototype; research clinical testing; sensor; simulation; size; success; two-dimensional

DESCRIPTION (provided by applicant): We propose to combine magnetic sensor (MN) navigation technology developed for prenatal cardiac intervention (R44HL076961) with our image overlay (IO) solutions to produce an accurate and user- accessible system for rapid, central vascular access (MNIO-VA). Central vascular access is the critical first step in many medical procedures (intravenous infusion of fluids, drugs, and blood; catheter access for intravascular procedures, hemodialysis, or pulsatile mechanical support; to name only a few). However, vascular access is frequently delayed or non-successful due to confounding conditions that include the small size of vessels in infants and children, distortion of vascular landmarks or vascular occlusion following trauma or previous procedures, patient movement during the time required to achieve access, and importantly, the loss of tactile landmarks in the setting of intravascular volume depletion or hypotension. The first needle pass for central vascular access often fails and causes bleeding and/or swelling adjacent to the target vessels which further reduces the likelihood for success. Current practice for acquiring central vascular access includes the use of surface and bony landmarks, tactile sensation, and for some procedures, 2-dimensional ultrasound imaging. However, current ultrasound systems visualize blood flow within vessels but do not provide navigation guidance for vascular access. We developed a robust solution for projecting the trajectory of a stylet and needle onto a 2- dimensional ultrasound image during prenatal (fetal) cardiac interventional procedures using real-time positional tracking of the ultrasound image plane via a magnetic field generator and sensor(s). Success with this system in aligning a needle to target (fetal aortic valve) along the preferred trajectory prior to entering the skin led to our decision to adapt this technology for use in central vascular access. We propose to develop a MNIO-VA solution using in vitro phantoms during this Phase I award to be followed by clinical trials in patients. Specific Aim 1. Adapt magnetic navigation (MN) and ultrasound image tracking solutions developed by our group for prenatal cardiac intervention (PCI) into a clinically intuitive line-of-sight image overlay (IO) solution to visualize the trajectories of needles to arteries and veins for rapid vascular access (VA). Specific Aim 2. Develop novel pulsatile vascular access phantoms that contain vessel pairs of varying diameters and depths and that simulate the 2D and color-Doppler characteristics of pulsatile arteries and veins for ultrasound-guided MNIO-VA training. Specific Aim 3. Test the speed and accuracy of a prototype MNIO-VA system using realistic, pulsatile arterial and venous vascular phantoms of varying vessel depths, diameters, and flow characteristics. General Relevance. Our proposed ultrasound-guided Magnetic Navigation, Image Overlay Vascular Access system will increase the speed, accuracy, and success of vascular access in infants and children and will reduce the complication rates associated with medical therapies that depend on central vascular access. Our proposed Magnetic Navigation, Image Overlay Vascular Access system will increase the speed, accuracy, and success of vascular access in infants and children and will both reduce the stress and increase the effectiveness of medical therapies that depend on central vascular access.

描述（由申请人提供）： 我们建议将专为产前心脏介入 (R44HL076961) 开发的磁传感器 (MN) 导航技术与我们的图像叠加 (IO) 解决方案相结合，以生成准确且用户可访问的系统，以实现快速的中央血管通路 (MNIO-VA)。中央血管通路是许多医疗手术中关键的第一步（静脉输注液体、药物和血液；血管内手术的导管通路、血液透析或脉动机械支持；仅举几例）。然而，由于一些混杂因素，血管通路经常被延迟或不成功，这些因素包括婴儿和儿童的血管尺寸小、血管标志变形或创伤或先前手术后的血管闭塞、在实现通路所需的时间内患者的移动、重要的是，在血管内容量不足或低血压的情况下，触觉标志会消失。用于中央血管通路的第一次针刺通常会失败，并导致目标血管附近出血和/或肿胀，这进一步降低了成功的可能性。当前获取中央血管通路的实践包括使用表面和骨标志、触觉，以及对于某些手术，使用二维超声成像。然而，当前的超声系统使血管内的血流可视化，但不提供血管通路的导航指导。我们开发了一种强大的解决方案，用于在产前（胎儿）心脏介入手术期间通过磁场发生器和传感器对超声图像平面进行实时位置跟踪，将管心针和针的轨迹投影到二维超声图像上。该系统成功地将针头在进入皮肤之前沿首选轨迹对准目标（胎儿主动脉瓣），这导致我们决定采用该技术用于中央血管通路。我们建议在第一阶段授予期间使用体外模型开发 MNIO-VA 解决方案，然后在患者中进行临床试验。具体目标 1. 将我们小组为产前心脏介入 (PCI) 开发的磁导航 (MN) 和超声图像跟踪解决方案改编为临床直观的视线图像叠加 (IO) 解决方案，以可视化针到动脉和的轨迹静脉用于快速血管通路（VA）。具体目标 2. 开发新型脉动血管通路模型，其中包含不同直径和深度的血管对，并模拟脉动动脉和静脉的 2D 和彩色多普勒特征，用于超声引导的 MNIO-VA 训练。具体目标 3. 使用具有不同血管深度、直径和血流特性的真实脉动动脉和静脉血管模型来测试原型 MNIO-VA 系统的速度和准确性。一般相关性。我们提出的超声引导磁导航、图像覆盖血管通路系统将提高婴儿和儿童血管通路的速度、准确性和成功率，并将降低与依赖中央血管通路的药物治疗相关的并发症发生率。我们提出的磁导航、图像覆盖血管通路系统将提高婴儿和儿童血管通路的速度、准确性和成功率，并且将减轻压力并提高依赖中央血管通路的医疗治疗的有效性。