Image-guided Fetal Cardiac Intervention

描述(由申请人提供)： 先天性心脏病的现代心脏外科治疗使矫正和姑息技术能够成功地应用于新生儿。然而，许多严重的心脏畸形会留下终身的心血管残疾和风险，这是因为这些心脏损害在胎儿时期对心肌结构和功能造成的累积损害。近年来，经皮和经腹膜腔内介入治疗妊娠2周和3个月早期的严重先天性心脏缺陷已被开发出来，在这些损害的自然病史导致心脏永久性发育损伤之前。这些新型介入方法的实践者目前面临的挑战本质上是技术性的，包括解释平面超声成像的困难，介入仪器的导航，胎儿的定位和固定，针对胎儿组织的尺寸和材料特性而优化的工具的设计和使用，以及进入胎儿心脏的精度和速度。对这些挑战的认识促使我们开发了图像引导技术的算法，使用实时3D超声和电磁引导仪器导航作为多模式平台来指导胎儿心脏介入治疗的表现。该小组的初步研究表明，使用这种方法可以极大地方便定位隐藏的胎儿解剖目标以进行精确的经皮介入治疗这一复杂但普遍的问题。这项提议的总体目标是通过集成实时3D超声成像、仪器的电磁导航和开发减少胎儿运动的设备来实现受控和可重复的胎儿心脏干预。为了实现这一目标，提出了一系列开发项目和实验，以解决以下具体目标：1)优化用于胎儿介入手术的治疗设备的实时3D超声和声学性能，2)将电磁导航与3D超声相结合，以实现精确的治疗计划以及成像和访问工具的协调空间跟踪，以及3)基于胎儿和母体组织的材料属性开发固定设备和插针技术。这些目标的成功完成将提高胎儿心脏介入治疗中任务执行的精确度、重复性、安全性和速度。PI已经组建了一支由大学和工业环境中的临床医生和工程师组成的团队，共同开展体外和体内研究，为这些和其他胎儿干预措施的进一步临床开发开发强大的程序算法和平台。

DESCRIPTION (provided by applicant): Modern cardiac surgical management of congenital heart defects allows corrective and palliative techniques to be applied successfully to the newborn. However, many with severe cardiac malformations are left with lifelong cardiovascular disability and risk due to the cumulative damage caused by these cardiac lesions on myocardial structure and function that occur during fetal life. Recently, percutaneous and transuterine interventional have been developed to treat severe congenital cardiac defects in the 2nd and early 3rd trimester of pregnancy, before the natural history of these lesions results in permanent developmental injury to the heart. The challenges currently facing practitioners of these novel interventional approaches are technical in nature, and include difficulties in interpretation of planar ultrasonographic imaging, navigation of interventional instruments, positioning and immobilization of the fetus, design and use of tools that are optimized to the dimensions and material properties of fetal tissue, and the precision and speed with which access to the fetal heart can be obtained. Identification of these challenges has prompted us to develop algorithms for image-guided techniques using real time 3D ultrasound and electromagnetically guided instrument navigation as a multimodal platform to guide performance of fetal cardiac interventions. Preliminary investigation by this group has shown that the complex but generalizable problem of locating a hidden fetal anatomical target for precise percutaneous intervention may be greatly facilitated using this approach. The overall goal of this proposal is to enable controlled and reproducible fetal cardiac intervention by integration of real time 3D ultrasound imaging, electromagnetic navigation of instruments and development of devices for reduction of fetal motion. To achieve this goal, a series of development projects and experiments is proposed to address the following specific aims: 1) optimize real time 3D ultrasound and acoustic properties of therapeutic devices for use in fetal interventional procedures, 2) integrate electromagnetic navigation with 3D ultrasound to enable precise treatment planning and coordinated spatial tracking of imaging and access tools, and 3) develop fixation instruments and needle insertion techniques based the material properties of fetal and maternal tissue. Successful completion of these aims will improve precision, reproducibility, safety and speed of task performance in fetal cardiac interventions. The PI has assembled a team of clinicians and engineers, based both in university and industrial environments, to work collaboratively on in vitro and in vivo studies to develop a robust procedural algorithm and platform for further clinical development of these and other fetal interventions.