Bedside 3D diagnostic imaging in ICU

ICU 床边 3D 诊断成像

• 批准号: 10369212
• 负责人: OTTO Z ZHOU
• 金额: $ 36.44万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-02-16 至 2024-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10369212
• 关键词: 3-Dimensional; Address; Algorithms; Anatomy; Area; Breast; Breast Cancer Detection; COVID-19 pandemic; COVID-19 patient; COVID-19 pneumonia; Calibration; Carbon Nanotubes; Catheters; Characteristics; Chest; Clinical; Collaborations; Critical Illness; Dental; Devices; Diagnosis; Diagnostic; Diagnostic Imaging; Digital Radiography; Dose; Engineering; Exposure to; Geometry; Goals; Gold; Image; Intensive Care; Intensive Care Units; Laboratory Research; Legal patent; Lung diseases; Measures; Mechanics; Medical; Medical Device; Methods; Notification; Orthopedics; Patient imaging; Patients; Performance; Phase; Physicians; Procedures; Process; Production; Pulmonary Heart Disease; Radiation; Radiation exposure; Radiology Specialty; Reproducibility; Roentgen Rays; Scientist; Source; System; Systems Integration; Technology; Testing; Thoracic Radiography; Three-Dimensional Imaging; Translating; Translational Research; Tube; Validation; Visualization; Voice; Work; X-Ray Computed Tomography; X-Ray Medical Imaging; base; cost; design; detector; diagnosis standard; diagnostic accuracy; diagnostic value; digital; experience; experimental study; follow-up; imaging capabilities; imaging modality; imaging study; imaging system; improved; innovation; novel; point of care; portability; prototype; radiologist; reconstruction; safety testing; simulation; software development; tomography; tomosynthesis

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).

ICU中的床边3D诊断成像 抽象的 重症监护室（ICU）的成像是患者管理不可或缺的一部分。床头胸部X射线射线照片 （CXR）是最经常要求的成像检查，用于通常遇到的肺部疾病 ICU，也通常用于评估各种导管和试管。在许多ICU传统中 实践为所有ICU患者授权每日CXR。它可以在该点检查重症患者 保养。在当前的199年大流行中，医生还使用床旁CXR进行随访 Covid肺炎。据估计，全球移动数字射线照相市场估计超过20亿美元 2017年，每年增长7％。 但是，作为2D成像方式，CXR的诊断精度受结构/解剖学的限制 重叠。设备，管和导管的叠加进一步降低了诊断质量。解释 CXR不仅要挑战重症监护医师，而且还挑战了放射科医生。计算机断层扫描（CT）是 目前用于诊断心肺疾病的金标准。但是，CT使用明显更高 暴露于患者和员工的辐射，与CXR相比，成本更高。除了 CT有一些特殊的目的系统，笨重且不流动。 我们建议通过开发移动数字来解决ICU更好诊断的未满足的临床需求 Tomosynsisses扫描仪可在患者的床边提供3D成像能力。数字间压合成（DTS） 通过从不同角度收集多个低剂量X射线图像来克服解剖学重叠的问题。 与CXR相比，它可以改善可视化和诊断性，并使用明显较低的剂量，并且具有 与CT相比，成本较低。现在，它在临床上被广泛用于检测乳腺癌，肺部疾病和 骨科成像。 DTS的使用有望改善ICU中的决策过程，但由于限制 在当前的技术中，尚未开发便携式DTS。提出的设备由多个 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 已经开发了概念验证DTS，并证明了其在患者成像研究中的实用性。目标的目标 项目是为专门用于ICU开发移动DTS设备。 该技术受到强大的专利组合的保护。新IP将在此项目中开发 加强保护。预计该设备需要从 FDA。该项目的具体目的是：（1）设计用于床边3D成像的移动DT（R61阶段）； （2）通过图像模拟和实验验证系统性能（R61相）； （3）原型 施工和验证（R33阶段）。