Computer Assisted Surgery Prenatal Cardiac Intervention

计算机辅助手术产前心脏干预

• 批准号: 6990341
• 负责人: CONSTANTINOS NIKOU
• 金额: $ 63.32万
• 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 2007-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6990341
• 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，外科手术修复心脏最有可能在婴儿期(此时有巨大的生长和重塑能力)取得成功。对于一部分患者来说，最佳干预时间是在出生前。目前的产前心脏介入(PCI)程序在胎儿可视化和器械方面显然都存在技术限制，需要长达220分钟，通常还需要为母亲进行进一步的手术。 全球假设：将定制的、计算机辅助的、外科可视化和导航技术整合到经皮冠状动脉介入治疗中，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变得更加健壮、准确和符合人体工程学。重复的体模实验将确认准确的可视化和定位性能，可以接受人类胎儿的应用。 具体目标2：优化计算机辅助冠状动脉介入治疗(CAPCI)用户界面，最大限度地减少手术时间。在目标2中，用户界面将进行优化，以提高易用性、速度、准确性和模拟经皮冠状动脉介入治疗期间的图像内容，从而克服第一阶段原型的限制。 具体目标3：在小动物和大动物试验中测试CAPCI提高的准确性和效率。在使用体外模体心脏靶点进行初步验证试验后，CAPCI系统的成功将通过将胎儿镜和气囊导管放置在成年大鼠的胸壁、左室心尖，然后穿过主动脉瓣的实验来确定。最后，进一步的实验将确定在妊娠中期的绵羊中，CAPCI导管穿过主动脉瓣的定位是否成功。这些实验将为开始临床试验提供原则性证据。 意义：开发计算机辅助的方法来优化经皮冠状动脉介入治疗将提高这些手术的准确性(并减少母体麻醉的时间)，直接影响手术的成功。这项技术对胎儿、儿童和成人的其他超声引导手术具有广泛的适用性。