A low-dose fluoroscope for pediatric interventional cardiology

描述（由申请人提供）：本申请涉及广泛的挑战领域（04）：临床研究和特定的挑战主题04- hd - 102*：儿科医疗器械的开发。儿童心脏干预的辐射剂量是一个严重的问题，因为儿童在暴露于辐射时患癌症的可能性远远大于成人。最好使用不依赖电离辐射的成像方式（如MRI、超声），但目前这些方式无法提供心脏干预所需的实时成像和空间分辨率性能。因此，我们建议开发一种介入心脏透视镜，以显著减少对儿童的辐射剂量。我们，三环技术和威斯康星大学，已经为导管实验室开发了一种面向成人的心脏血管造影系统，计划于2009年秋季发布。该系统采用了一种新颖的成像几何结构，包括基于传输目标的扩展扫描束x射线源和像素化光子计数探测器。最终的图像由多达10,000个实时重建的探测器图像组成。这种扫描束数字x射线（SBDX）系统被设计并证明可以减少成人患者10倍的辐射暴露。由于儿童的体型和程序要求较小，预计这些节余较少。然而，我们相信，SBDX系统的独特设计将允许实施额外的剂量节约策略，使儿科患者受益，这在传统系统中是不可能的。这些是：（具体目标1）使用一种新型靶标与具有增强光谱组成的光束过滤相结合，以提高碘的图像对比度；（具体目标2）能量分辨检测，进一步增强图像对比度；（具体目标3）电子空间波束整形，包括ROI滤波、准直和均衡滤波，不依赖于机械滤波器或百叶窗。我们将在拟人化儿童幻影与传统系统和拟议的儿科SBDX系统的比较研究中验证我们的方法（具体目标4）。我们认为，与使用儿科环境的传统系统相比，这些策略将使儿童的辐射剂量减少75%。儿童心脏干预的辐射剂量是一个严重的问题，因为在生命的头十年接受辐射的儿童患癌症的风险比一般人群高几倍。最好使用不依赖电离辐射的成像技术（如MRI、超声），但目前这些技术无法提供心脏干预所需的实时成像和空间分辨率性能。因此，我们的目标是开发和建立一个用于儿科心脏干预的原型透视镜，与使用儿科设置的传统系统相比，它将使儿童的辐射剂量减少75%。

DESCRIPTION (provided by applicant): This application addresses broad Challenge Area (04): Clinical Research and specific Challenge Topic 04-HD- 102*: Development of Pediatric Medical Devices. Radiation dose in pediatric cardiac interventions is a serious concern because of the far greater likelihood for children to develop cancer when exposed to radiation than adults. It is preferable to use imaging modalities that do not rely on ionizing radiation (e.g. MRI, ultrasound), but currently these modalities cannot provide the real time imaging and spatial resolution performance necessary for cardiac interventions. Therefore, we propose to develop an interventional cardiac fluoroscope that will significantly reduce the radiation dose to children. We, Triple Ring Technologies and the University of Wisconsin, have developed an adult-oriented cardiac angiography system for the catheterization laboratory, scheduled for release in fall 2009. The system employs a novel imaging geometry with an extended, scanning-beam X-ray source based on a transmission target, and a pixelated photon counting detector. The final image is composed of up to 10,000 detector images that are reconstructed in real time. This scanning-beam digital X-ray (SBDX) system was designed and proven to reduce radiation exposure in adult patients as much as 10-fold. These savings are expected to be smaller in children due to their smaller size and procedural requirements. However, we believe that the unique design of the SBDX system will allow the implementation of additional dose saving strategies benefiting pediatric patients that are not possible in conventional systems. These are: (Specific Aim 1) Use of a novel target in combination with beam filtration that has an enhanced spectral composition to improve image contrast for iodine; (Specific Aim 2) Energy-resolved detection to further enhance image contrast; and (Specific Aim 3) Electronic spatial beam shaping including ROI filtration, collimation, and equalization filtration that does not rely on mechanical filters or shutters. We will validate our approach in a comparative study of anthropomorphic pediatric phantoms with a conventional system and the proposed pediatric SBDX system (Specific Aim 4). We believe these strategies will reduce radiation dose in children by 75% as compared to conventional systems using pediatric settings. Radiation dose in pediatric cardiac interventions is a serious concern because children who receive radiation in the first decade of life have a several fold higher risk of developing cancer than the average population. It is preferable to use imaging technologies that do not rely on ionizing radiation (e.g. MRI, ultrasound), but currently these technologies cannot provide the real-time imaging and spatial resolution performance necessary for cardiac interventions. Therefore, we aim to develop and build a prototype fluoroscope for pediatric cardiac interventions that will reduce the radiation dose to children by 75% as compared to conventional systems using pediatric settings.