Image-guided Intravascular Robotic System for Mitral Valve Repair and Implants

二尖瓣返流（MR）是最常见的瓣膜病变之一，影响900万美国人， 会增加发病率和死亡率。二尖瓣返流是由于血液通过二尖瓣渗漏而发生的， 诱发左心室容量超负荷，增加舒张期室壁应力， 扩张，最终导致5年内充血性心力衰竭和死亡。及时有效地修复 MR对于阻止心力衰竭的进展至关重要，但目前的选择有限。开启- 心脏手术是目前的护理标准，并且具有相对高的术后死亡风险。 经导管二尖瓣修复术是一种新型技术，其中MR修复是在跳动下进行的 使用被引导至二尖瓣以部署修复装置的导管来植入心脏。然而，通往 二尖瓣对于现有导管来说是一条具有挑战性的道路。与其相关的复杂性 在跳动的心脏中植入，通常导致手术失败并转换为心脏直视手术。 我们建议开发一种新型的血管内可操纵机器人，通过以下方式引导到二尖瓣 多模态成像，并部署了一种新型的，低轮廓的设备，可以有效地修复所有形式的MR。在 四年来，我们建议完成四个具体目标：具体目标1（GT-Desai）：设计和开发一个 具有多个自由度的铰接式中空机器人导管探针，以将植入物朝向 超出二尖瓣开口，以及定向植入物以在瓣膜小叶上精确展开。的 机器人将具有近端和远端滚动关节的能力，沿着具有弯曲连杆能力 夹在两个滚动关节之间;具体目标2（Emory-Fei）：设计多模态图像引导 导航和可视化平台，用于配准和可视化三维（3D）超声心动图 和X射线荧光透视检查，并提供了一个实时图像引导的导航和可视化系统， 临床医生通过最佳路径操纵机器人到达目的地，定位精度≤ 3 mm;具体目标3（Emory-Padala）：确定三种二尖瓣植入物增加 与血管内机器人系统配合使用以实现二尖瓣修复的复杂性;具体目标4 (GT+Emory）：验证可操纵机器人导管系统的安全性和有效性， 人类使用是无缝的。将对集成系统（机器人+成像+植入物）进行系统测试， 在脉动流体模、离体猪、跳动的心脏人尸体和慢性体内 猪二尖瓣疾病的研究。 这个高度创新和跨学科的项目结合了外科机器人技术的专业知识（德赛-BME， GT）、成像（Fei-Radiology，Emory）和二尖瓣修复器械（Padala，Guyton-Surgery，Emory）。我们设想 由多模态成像引导的血管内可操纵机器人和植入物将显著简化 经导管二尖瓣修复术，提高手术准确性和控制性，降低失败率。

Mitral regurgitation (MR) is one of the most common valve lesions, which affects 9 million Americans, and is known to increase morbidity and mortality. MR occurs due to leakage of blood through the mitral valve and induces volume overload on the left ventricle, elevates diastolic wall stress and causes rapid left ventricular dilatation, ultimately leading to congestive heart failure within 5 years and death. Timely and effective repair of MR is of utmost importance to halt the progression of heart failure, but current options are limited. Open- heart surgery is the current standard of care and has a relatively high risk of post-operative mortality. Transcatheter mitral valve repair, is a new class of technologies in which MR repair is performed on a beating heart using a catheter that is guided to the mitral valve to deploy reparative devices. However, the route to the mitral valve is a challenging path for existing catheters to follow. The complexity associated with their implantation in a beating heart, often leads to failed procedures and conversion to open heart surgery. We propose to develop a novel intravascular steerable robot that is guided to the mitral valve by multimodality imaging and deploys a novel, low profile device that can effectively repair MR of all forms. In four years, we propose to complete four specific aims: Specific Aim 1 (GT-Desai): Design and develop an articulated hollow robotic catheter probe with multiple degrees-of-freedom to steer the implant towards and beyond the mitral valve opening as well as orient the implant for accurate deployment on the valve leaflet. The robot will have the capability of both proximal and distal roll joint along with a bending link capability sandwiched between the two roll joints; Specific Aim 2 (Emory-Fei): Design a multimodality image-guided navigation and visualization platform that registers and visualizes three-dimensional (3D) echocardiography and X-ray fluoroscopy and provides a real-time image-guided navigation and visualization system for the clinician to manipulate the robot to the destination through an optimal path with a localization accuracy of ≤ 3 mm; Specific Aim 3 (Emory-Padala): Determine the efficacy of three mitral valve implants of increasing complexity for use with the intravascular robotic system to enable mitral valve repair; Specific Aim 4 (GT+Emory): Validate the safety and efficacy of the steerable robotic catheter system such that its translation to human use is seamless. The integrated system (robot + imaging + implant) will be systematically tested and optimized in pulsatile flow phantoms, ex vivo swine, beating heart human cadavers, and in chronic in vivo studies in swine induced with mitral valve disease. This highly innovative and interdisciplinary project combines expertise in surgical robotics (Desai-BME, GT), imaging (Fei-Radiology, Emory) and mitral repair devices (Padala, Guyton-Surgery, Emory). We envision that the intravascular steerable robot and implant, guided by multimodality imaging will significantly simplify Transcatheter mitral valve repair, increasing the procedural accuracy and control, and reducing failure rates.