Image-guided Fetal Cardiac Intervention

描述（由申请人提供）： 现代心脏外科治疗先天性心脏病允许纠正和姑息技术成功地应用于新生儿。然而，许多严重心脏畸形患者由于在胎儿期发生的这些心脏病变对心肌结构和功能造成的累积损伤而留下终身心血管残疾和风险。最近，经皮和经子宫介入已被开发用于治疗妊娠第2和第3早期的严重先天性心脏缺陷，在这些病变的自然史导致心脏永久性发育损伤之前。这些新型介入方法的从业者目前面临的挑战本质上是技术性的，并且包括平面超声成像的解释、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进行优化的工具的设计和使用以及可以获得进入胎儿心脏的精度和速度方面的困难。识别这些挑战促使我们开发图像引导技术的算法，使用真实的三维超声和电磁引导仪器导航作为多模式平台，以指导胎儿心脏介入的性能。该小组的初步研究表明，使用这种方法可能会大大促进定位一个隐藏的胎儿解剖靶点进行精确的经皮介入的复杂但可推广的问题。该提案的总体目标是通过整合真实的实时3D超声成像、仪器的电磁导航和用于减少胎儿运动的设备的开发来实现受控和可再现的胎儿心脏介入。为实现这一目标，提出了一系列发展项目和实验，以实现以下具体目标：1）优化用于胎儿介入过程的治疗设备的真实的3D超声和声学特性，2）将电磁导航与3D超声集成，以实现精确的治疗规划和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特性开发固定器械和针插入技术。这些目标的成功完成将提高胎儿心脏介入治疗的精确性、可重复性、安全性和任务执行速度。PI已经组建了一个由临床医生和工程师组成的团队，他们来自大学和工业环境，在体外和体内研究中合作，为这些和其他胎儿干预的进一步临床开发一个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.