Computer Assisted Surgery Prenatal Cardiac Intervention

计算机辅助手术产前心脏干预

• 批准号: 7124187
• 负责人: CONSTANTINOS NIKOU
• 金额: $ 39.84万
• 依托单位: CASURGICA, INC.
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-03-01 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7124187
• 关键词: aortic valve; bioimaging /biomedical imaging; computer assisted patient care; computer system design /evaluation; computer system hardware; embryo /fetus surgery; heart surgery; image guided surgery /therapy; laboratory rat; phantom model; sheep

DESCRIPTION (provided by applicant): There is growing recognition that surgical repair of the heart is most likely to be successful in infancy (when there is dramatic capacity for growth and remodeling). For a subset of patients, the optimal time for intervention is prior to birth. Current prenatal cardiac intervention (PCI) procedures clearly have technical limitations in both fetal visualization and instrumentation, taking up to 220 minutes, and often further surgery for the mother. Global Hypothesis: Integration of customized, computer-assisted, surgical visualization and navigation techniques into PCI will reduce procedural time and improve accuracy leading to improved fetal outcomes. The Phase II Specific Aims are: Specific Aim 1: Optimize software and hardware to exceed accuracy requirements for fetal probe positioning and tracking. Integration of new high-resolution ultrasound and tracking equipment will optimize system accuracy and image quality. The ultrasound probe calibration protocols will be made more robust, accurate, and ergonomic. Repeat phantom experiments will confirm accurate visualization and localization performance acceptable for human fetal application. Specific Aim 2: Optimize the computer-assisted PCI (CAPCI) user interface to maximally reduce procedure time. In Aim 2 the user interface will be optimized to increase ease of use, speed, accuracy, and image content during simulated PCI, overcoming the limitations of the Phase I prototypes. Specific Aim 3: Test the increased accuracy and efficiency of CAPCI in small and large animal trials. Following initial validation trials using in vitro phantom heart targets, the success of the CAPCI system will be determined by experiments that position a fetoscope and balloon catheter through the chest wall, left ventricular apex, and then across the aortic valve of an adult rat. Finally, further experiments will determine the success of CAPCI in catheter positioning across the aortic valve in the mid-gestation fetal sheep. These experiments will provide proof of principle to begin clinical trials. Significance: The development of computer-assisted methods to optimize PCI will increase the accuracy (and reduce the length of maternal anesthesia) of these procedures with a direct impact on procedural success. This technology has broad applicability to other ultrasound-guided procedures in the fetus, child, and adult.

描述（由申请人提供）： 越来越多的人认识到，心脏的手术修复在婴儿期最有可能成功（当有巨大的生长和重塑能力时）。对于一部分患者，干预的最佳时间是出生前。目前的产前心脏介入治疗（PCI）程序在胎儿可视化和仪器方面显然具有技术局限性，需要长达220分钟，并且通常需要对母亲进行进一步的手术。 全局假设：将定制的计算机辅助手术可视化和导航技术集成到PCI中将减少手术时间并提高准确性，从而改善胎儿结局。 第二阶段的具体目标是： 具体目标1：优化软件和硬件，以超过胎儿探头定位和跟踪的精度要求。新的高分辨率超声和跟踪设备的集成将优化系统精度和图像质量。超声探头校准方案将更加稳健、准确和符合人体工程学。重复体模实验将确认准确的可视化和定位性能对于人类胎儿应用是可接受的。 具体目标2：优化计算机辅助PCI（CAPCI）用户界面，以最大限度地缩短手术时间。在Aim 2中，将优化用户界面，以提高模拟PCI期间的易用性、速度、准确性和图像内容，克服I期原型的局限性。 具体目标3：在小型和大型动物试验中测试CAPCI的准确性和效率。在使用体外体模心脏目标的初始验证试验之后，CAPCI系统的成功将通过将胎儿镜和球囊导管定位通过胸壁、左心室尖然后穿过成年大鼠的主动脉瓣的实验来确定。最后，进一步的实验将确定CAPCI在妊娠中期胎羊主动脉瓣上导管定位的成功性。这些实验将为开始临床试验提供原理证明。 重要性：开发计算机辅助方法来优化PCI将提高这些手术的准确性（并缩短产妇麻醉时间），对手术成功产生直接影响。该技术广泛适用于胎儿、儿童和成人的其他超声引导手术。