Bedside 3D diagnostic imaging in ICU

ICU床旁3D诊断成像 摘要 重症监护室（ICU）中的成像是患者管理的一个组成部分。床旁胸部X线片 (CXR)是最常见的肺部疾病， ICU，也常规用于各种导管和管道的评估。在许多传统的ICU 实践要求所有ICU患者每天进行CXR。它可以在关键时刻对危重病人进行检查- 护理。在当前的COVID-19大流行中，医生还使用床旁CXR对患有以下疾病的患者进行随访： 新冠肺炎。年，全球移动的数字X射线摄影市场估计超过20亿美元。 2017年，年增长率为7%。 然而，作为一种2D成像模式，CXR的诊断准确性受到结构/解剖学的限制。 重叠。器械、管和导管的叠加进一步降低了诊断质量。解释 CXR不仅对重症监护医生而且对放射科医生都具有挑战性。计算机断层扫描（CT）是 目前诊断心肺疾病的金标准。然而，CT使用明显更高的 对患者和工作人员的辐射暴露，并且与CXR相比具有更高的成本。但不包括 在一些特殊用途的系统中，CT体积大、重量重并且不能移动的。 我们建议通过开发一种移动的数字化诊断系统， 断层合成扫描仪，以在患者床边提供3D成像能力。数字化断层合成 通过从不同角度收集多个低剂量X射线图像克服了解剖学重叠的问题。 与CXR相比，它改善了可视化和诊断，使用的剂量显著降低， 与CT相比，成本更低。它现在被广泛用于临床检测乳腺癌，肺部疾病和 骨科影像学预计使用ESTA将改善ICU的决策过程，但由于其局限性， 在当前的技术中，还没有开发出便携式RFID。所提出的装置通过多个 创新包括我们团队发明的新型碳纳米管（CNT）x射线源阵列技术。我们 已经开发了一种概念验证的方法，并证明了其在患者成像研究中的实用性。这个目标 项目是专门为ICU开发一种移动的监护设备。 该技术受到强大的专利组合的保护。在本项目期间将开发新的IP， 加强保护。该器械预计需要获得上市前通知（510（K））批准， FDA。本课题的具体目标是：（1）设计一种用于床边三维成像的移动的床旁三维成像系统（R61阶段）; (2)通过图像仿真和实验（R61阶段）验证了系统的性能;（3）原型 构建和验证（R33阶段）。

Bedside 3D diagnostic imaging in ICU ABSTRACT Imaging in intensive care unit (ICU) is an integral part of patient management. Bedside chest x-ray radiograph (CXR) is the most often requested imaging examination for the commonly encountered pulmonary diseases in the ICU and is also routinely used for the assessment of various catheters and tubes. In many ICU traditional practice mandates a daily CXR for all ICU patients. It enables examination of the critically ill patients at the point- of-care. In the current COVID-19 pandemic, physicians also use bedside CXR for follow-up of patients with COVID pneumonia. The global market for mobile digital radiography was estimated to be over USD 2 billion in 2017, growing at an annual rate of 7%. However, as a 2D imaging modality the diagnostic accuracy of CXR is limited by structural/anatomical overlaps. Superposition of devices, tubes and catheters further reduce the diagnostic quality. Interpretation of CXR is challenging not only for intensive care physicians but also for radiologist. Computed tomography (CT) is the current gold standard for diagnosis of cardiopulmonary diseases. However, CT uses a significantly higher radiation exposure to the patients and the staff, and has a higher cost compared to CXR. With the exception of a few special purpose systems, CT is in bulky and heavy and is not mobile. We propose to address this unmet clinical need of better diagnosis at the ICU by developing a mobile digital tomosynthesis scanner to provide 3D imaging capability at the patient bedside. Digital tomosynthesis (DTS) overcomes the problem of anatomical overlap by collecting multiple low-dose x-ray images from different angles. It improves the visualization and diagnosis compared to CXR and uses a significantly lower dose and has a lower cost compared to CT. It is now widely used clinically for detection of breast cancer, lung disease and orthopedic imaging. The use of DTS is expected to improve the decision process in the ICU, but due to limitations of the current technologies, no portable DTS has been developed. The proposed device is enabled by multiple innovations including a novel carbon nanotube (CNT) x-ray source array technology invented by our team. We have developed a proof-of-concept DTS and demonstrated its utility in patient imaging studies. The goal of this project is to develop a mobile DTS device specifically for ICU. The technology is protected by a strong patent portfolio. New IP’s will be developed during this project to strengthen the protection. The device is expected to require the Pre-market Notification (510(K)) approval from the FDA. The Specific Aims of this project are: (1) Designing a mobile DTS for bedside 3D imaging (R61 Phase); (2) Validating the system performance by image simulation and experiment (R61 Phase); and (3) Prototype construction and validation (R33 Phase).