Magnetic Navigated Image Overlay for Vascular Access - MNIO-VA

描述（由申请人提供）： 我们建议将为产前心脏介入（R44 HL 076961）开发的联合收割机磁传感器（MN）导航技术与我们的图像覆盖（IO）解决方案相结合，以产生一种用于快速中心血管通路（MNIO-VA）的准确且用户可访问的系统。中央血管通路是许多医疗程序中关键的第一步（流体、药物和血液的静脉内输注;用于血管内程序、血液透析或脉动机械支持的导管通路;仅举几例）。然而，由于混杂条件，包括婴儿和儿童的血管尺寸小、创伤或既往手术后血管标志扭曲或血管闭塞、在实现通路所需的时间内患者移动，以及重要的是，在血管内容量不足或低血压的情况下触觉标志丢失，血管通路经常延迟或不成功。用于中心血管通路的第一针通过通常失败，并导致邻近靶血管的出血和/或肿胀，这进一步降低了成功的可能性。当前用于获取中央血管通路的实践包括使用表面和骨标志、触觉，并且对于某些程序，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，但不提供用于血管通路的导航引导。我们开发了一种强大的解决方案，用于在产前（胎儿）心脏介入手术期间使用经由磁场发生器和传感器的超声图像平面的实时位置跟踪将探针和针的轨迹投影到二维超声图像上。该系统在进入皮肤之前成功地将针沿着首选轨迹对准目标（胎儿主动脉瓣），这促使我们决定将该技术用于中心血管通路。我们建议在I期研究期间使用体外模型开发MNIO-VA溶液，然后在患者中进行临床试验。具体目标1。将我们团队开发的用于产前心脏介入（PCI）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覆盖（IO）解决方案，以可视化针头到动脉和静脉的轨迹，从而实现快速血管通路（VA）。具体目标2。开发新型脉动血管通路体模，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培训。具体目标3。使用具有不同血管深度、直径和流量特性的真实脉动动脉和静脉血管模型测试原型MNIO-VA系统的速度和准确度。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，并将降低与依赖中心血管通路的医学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，并将减少压力并提高依赖于中央血管通路的医学治疗的有效性。

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.