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）：临床研究和特定挑战主题04-HD- 102*：儿科医疗器械的开发。儿科心脏介入治疗中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比成人大得多。优选使用不依赖于电离辐射的成像模态（例如MRI、超声），但是目前这些模态不能提供心脏介入所需的真实的时间成像和空间分辨率性能。因此，我们建议开发一种介入性心脏荧光镜，可以显著降低儿童的辐射剂量。我们，三环技术公司和威斯康星州大学，已经为导管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的成像几何形状，扩展的扫描束X射线源的基础上的传输目标，和像素化的光子计数探测器。最终图像由多达10，000个探测器图像组成，这些图像是真实的时间重建的。这种扫描束数字X射线（SBDX）系统的设计和证明，以减少辐射暴露在成人患者多达10倍。由于儿童的体型较小和手术要求，这些储蓄预计会较小。然而，我们认为SBDX系统的独特设计将允许实施额外的剂量节省策略，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）使用新型靶点结合具有增强光谱组成的射束过滤，以改善碘的图像对比度;（具体目标2）能量分辨检测，以进一步增强图像对比度;以及（具体目标3）电子空间射束整形，包括ROI过滤、准直和不依赖于机械过滤器或快门的均衡过滤。我们将在一项拟人儿科体模与传统系统和拟议的儿科SBDX系统（具体目标4）的比较研究中验证我们的方法。我们相信，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%。儿科心脏介入治疗中的辐射剂量是一个严重的问题，因为在生命的前十年接受辐射的儿童患癌症的风险比普通人群高出数倍。最好使用不依赖电离辐射的成像技术（例如MRI、超声），但目前这些技术无法提供心脏介入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构建一种用于儿科心脏介入的原型荧光镜，与使用儿科环境的传统系统相比，该原型荧光镜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.