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

用于二尖瓣修复和植入的图像引导血管内机器人系统

• 批准号: 10117090
• 负责人: JAYDEV P. DESAI
• 金额: $ 71.37万
• 依托单位: GEORGIA INSTITUTE OF TECHNOLOGY
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-03-15 至 2023-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10117090
• 关键词: 3-Dimensional; Affect; American; Blood; Blood Circulation; Blood Vessels; Blood flow; Cadaver; Cardiac; Cardiac Surgery procedures; Cardiomyopathies; Catheters; Cessation of life; Chronic; Clinical; Congestive Heart Failure; Destinations; Deterioration; Devices; Dilatation - action; Disease; Distal; Echocardiography; Europe; Extravasation; FDA approved; Failure; Family suidae; Femoral vein; Fluoroscopy; Freedom; Goals; Heart; Heart failure; Hemorrhage; Human; Image; Implant; Interatrial septum; Joints; Left; Left atrial structure; Left ventricular structure; Lesion; Link; Manuals; Mitral Valve; Mitral Valve Insufficiency; Morbidity - disease rate; Multimodal Imaging; Obstruction; Operative Surgical Procedures; Patients; Postoperative Period; Procedures; Pulsatile Flow; Pump; Puncture procedure; Quality of life; Radiology Specialty; Right atrial structure; Risk; Robot; Robotics; Roentgen Rays; Route; Safety; Side; Stenosis; Stress; Stroke; Structure; Symptoms; System; Technology; Testing; Therapeutic; Three-Dimensional Echocardiography; Time; Trauma; Venous; Ventricular; Visualization; design; flexibility; high risk; image guided; image guided intervention; implantation; improved; in vivo; innovation; mortality; mortality risk; novel; real-time images; repaired; robotic system; standard of care; translation to humans

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.

二尖瓣返流(MR)是最常见的瓣膜病变之一，影响900万美国人， 已知会增加发病率和死亡率。MR是由于血液通过二尖瓣渗漏而发生的 导致左心室容量超负荷，增加舒张期壁应力，导致左心室快速收缩 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。打开- 心脏手术是目前的护理标准，手术后死亡率相对较高。 经导管二尖瓣成形术是一种新型的技术，它是在心脏跳动的情况下进行二尖瓣成形术。 使用导管将心脏送入二尖瓣，以部署修复装置。然而，通往 对于现有的导管来说，二尖瓣是一条具有挑战性的路径。与其相关的复杂性 植入不停跳的心脏，往往会导致失败的手术和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，它通过以下方式引导到二尖瓣 多模式成像，并部署了一种新颖的低调设备，可以有效地修复所有形式的MR。在……里面 四年来，我们计划完成四个具体目标：具体目标1(GT-DESAI)：设计和开发一个 多自由度铰接式空心机器人导管探头，可将植入物朝向 在二尖瓣开口之外放置植入物，并将植入物定向到瓣叶上准确展开。这个 机器人将具有近端和远端侧倾关节的能力以及弯曲连接能力 夹在两个滚动节之间；具体目标2(Emory-Fei)：设计一种多通道图像引导 注册和可视化三维(3D)超声心动图的导航和可视化平台 和X射线透视，并提供实时图像引导导航和可视化系统 临床医生通过最优路径操纵机器人到达目的地，定位精度为≤3 具体目标3(Emory-Padala)：确定三种二尖瓣置入术的疗效 血管内机器人系统用于二尖瓣修复术的复杂性.具体目标4 (GT+Emory)：验证可定向机器人导管系统的安全性和有效性，以便其翻译 对人类的使用是无缝的。将对集成系统(机器人+成像+植入)进行系统测试和 在脉动流动模体、体外猪、心脏跳动的人身体和慢性体内进行了优化 二尖瓣病猪模型的研究。 这个高度创新的跨学科项目结合了外科机器人技术(DESAI-BME， 成像(Fei-Radiology，Emory)和二尖瓣修复器(Padala，Guyton-Surgery，Emory)。我们设想 在多模式成像的引导下，血管内可控机器人和植入物将显著简化 经导管二尖瓣修复术，提高了程序的准确性和控制性，并降低了失败率。

项目成果

Patient-specific computational biomechanical modeling to guide mitral valve repair strategy: Practicality and value?

用于指导二尖瓣修复策略的针对患者的计算生物力学模型：实用性和价值？

• DOI: 10.1016/j.jtcvs.2017.09.132
• 发表时间: 2018
• 期刊: The Journal of thoracic and cardiovascular surgery
• 作者: Padala,Muralidhar

Effect of early versus late onset mitral regurgitation on left ventricular remodeling in ischemic cardiomyopathy in an animal model.

• DOI: 10.1016/j.jtcvs.2021.11.024
• 发表时间: 2022-12
• 期刊: JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
• 影响因子: 6
• 作者: Kono, Takanori;Onohara, Daisuke;Amedi, Alan;Corporan, Daniella;Padala, Muralidhar
• 通讯作者: Padala, Muralidhar

Towards the Design and Development of a Robotic Transcatheter Delivery System for Mitral Valve Implant.

• DOI: 10.1109/tmrb.2022.3215522
• 发表时间: 2022-11
• 期刊: IEEE TRANSACTIONS ON MEDICAL ROBOTICS AND BIONICS
• 作者: Nayar, Namrata U.;Qi, Ronghuai;Desai, Jaydev P.
• 通讯作者: Desai, Jaydev P.

A heart valve is no stronger than its weakest link: The need to improve durability of pericardial leaflets.

心脏瓣膜的强度并不比其最薄弱的环节强：需要提高心包小叶的耐用性。

• DOI: 10.1016/j.jtcvs.2018.03.034
• 发表时间: 2018
• 期刊: The Journal of thoracic and cardiovascular surgery
• 作者: Padala,Muralidhar

Patient-Specific Three-Dimensional Ultrasound Derived Computational Modeling of the Mitral Valve.

患者特定的三维超声衍生的二尖瓣计算模型。

• DOI: 10.1007/s10439-022-02960-x
• 发表时间: 2022
• 期刊: Annals of biomedical engineering
• 影响因子: 3.8
• 作者: Gaidulis,Gediminas;Suresh,KirthanaSreerangathama;Xu,Dongyang;Padala,Muralidhar
• 通讯作者: Padala,Muralidhar