Pulsed Focused Ultrasound (pFUS) exposures and devices for tissue permeabilization without contrast agents

脉冲聚焦超声 (pFUS) 曝光和无需造影剂的组织透化装置

基本信息

批准号：
10208594
负责人：
Tatiana Khokhlova
金额：
$ 30.67万
依托单位：
UNIVERSITY OF WASHINGTON
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-01-19 至 2021-09-18
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10208594
关键词：
Acoustics Adhesives Algorithmic Analysis Algorithms Alveolar Anatomy Award Bacterial Pneumonia Bilateral COVID-19 COVID-19 patient Characteristics China Clinic Contrast Media Controlled Environment Critical Illness Data Detection Devices Diagnosis Diagnostic Dialysis procedure Disease Drug Delivery Systems Edema Electrocardiogram Elements Emergency Department patient Emergency Situation Environment Europe Evaluation Exposure to Focused Ultrasound Frequencies Human Subject Research Hypoxemia Image Individual Kidney Calculi Licensing Location Lung Manufacturer Name Maps Mechanics Medical Monitor Morphologic artifacts Morphology Patient Monitoring Patient imaging Patients Pattern Periodicity Physiologic pulse Pleural Pneumonia Porifera Process Protocols documentation Provider Public Health Pulmonary Edema Pulmonary Pathology Radiation Recommendation Reporting Risk Role Sales Severities Shapes Signal Transduction Slide Solid Neoplasm Standardization Structure of parenchyma of lung Surface System Technology Testing Thick Thoracic Radiography Time TimeLine Tissues Training Triage Ultrasonography United States Viral Pneumonia Virus Visualization Water automated algorithm base chest computed tomography clinical decision-making commercialization design efficacy evaluation experience flexibility imaging modality imaging platform imaging probe indexing instrumentation interstitial prototype sensor signal processing stem therapeutic evaluation tool

项目摘要

PROJECT SUMMARY According to recent reports from across the world, the need to continuously evaluate lung edema in critically ill COVID-19 patients is essential. Chest x-ray has reduced sensitivity early in the disease; the contagiousness of the virus and the risk of transporting unstable patients with hypoxemia make chest CT a limited option for the patient with suspected or established COVID-19. Lung ultrasound (LUS) is non-ionizing and safe, and has recently emerged as a useful triage and monitoring tool for lung edema quantification in COVID-19 patients. In LUS, imaging artifacts termed A-lines (periodic horizontal lines parallel to the lung surface indicating a normal aeration pattern) and B-lines (comet-like hyperechoic regions indicating an alveolar or interstitial abnormality) are evaluated. B-lines stem from acoustic reverberations within regions of alveolar edema, and their number and thickness are known to be correlated with edema severity. However, visualization and quantification of B-lines requires substantial training, and even then, are highly operator and machine dependent. This is in part due to a still incomplete understanding of the exact physical mechanism of B-line formation. In this emergency competitive revision to the current award on ultrasound cavitation-aided drug delivery to solid tumors we propose to build on our expertise in dissecting the origins of US imaging artifacts and ultrasound instrumentation capabilities to 1) identify the origins of B-line artifact in LUS and specific associated RF signal features, and 2) based on the attained understanding, develop a single-element, wearable, automated, non-imaging lung ultrasound sensor (LUSS) for continuous monitoring of lung pathology while minimizing provider time, risk of virus exposure, and radiation. Individual adhesive LUSS elements will be attached to patients in specific anatomic locations similarly to ECG leads, and ultrasound signals will be collected and processed with automated algorithms to provide lung edema score that can be used in clinical decision making. We have designed a proof of principle study scaled to the shortest timeline possible to get the device into the clinic quickly, with the following specific aims. In SA1 we will perform standard LUS exams in non-COVID patients with cardiogenic pulmonary edema while collecting raw RF signal data to understand the manifestation of B-lines in raw RF signals and develop automated signal processing algorithm. In SA2 we will design and fabricate single- element LUSS prototype and validate the automated signal processing algorithm against LUS imaging in lung- mimicking sponge-based phantom. By the end of the 9-month project the prototype device will be ready for use in not only COVID19 patients, but other ED patients for whom continuous evaluation of lung condition is essential (bacterial pneumonia, cardiogenic edema, dialysis). Our commercialization approach here is to broadly license this simple technology so that large ultrasound manufacturers with broad sales and distribution capabilities can get the technology to the users.

项目概要根据世界各地最近的报告，需要持续评估危重病人的肺水肿 COVID-19 患者至关重要。胸部 X 光检查在疾病早期降低了敏感性；的传染性病毒以及转运患有低氧血症的不稳定患者的风险使得胸部 CT 成为了有限的选择疑似或确诊的 COVID-19 患者。肺部超声 (LUS) 是非电离且安全的，并且具有最近成为一种有用的分诊和监测工具，用于量化 COVID-19 患者的肺水肿。在 LUS，称为 A 线的成像伪影（平行于肺表面的周期性水平线，指示正常通气模式）和 B 线（彗星状高回声区域，表明肺泡或间质异常）被评估。 B 线源于肺泡水肿区域内的声学混响，及其数量和已知厚度与水肿严重程度相关。然而，B 线的可视化和量化需要大量培训，即使如此，也高度依赖操作员和机器。这部分是由于对 B 线形成的确切物理机制仍不完全了解。在这紧急情况下我们建议对目前超声空化辅助实体瘤药物输送奖项进行竞争性修订以我们在剖析美国成像伪影和超声仪器起源方面的专业知识为基础 1) 识别 LUS 中 B 线伪影的起源和特定的相关 RF 信号特征，以及 2) 基于所获得的理解，开发单元件、可穿戴、自动化、非成像肺超声传感器 (LUSS) 用于连续监测肺部病理，同时最大限度地减少提供时间、风险病毒暴露和辐射。单独的 LUSS 粘合元件将按照特定的方式贴在患者身上解剖位置类似于心电图导联，超声信号将被收集和处理自动化算法提供可用于临床决策的肺水肿评分。我们有设计了一项原理证明研究，尽可能在最短的时间内将设备快速投入临床，具有以下具体目标。在 SA1 中，我们将对非新冠肺炎患者进行标准 LUS 检查心源性肺水肿，同时收集原始射频信号数据以了解 B 线的表现原始射频信号并开发自动信号处理算法。在SA2中，我们将设计和制造单 element LUSS 原型并根据肺中的 LUS 成像验证自动信号处理算法模仿基于海绵的模型。为期 9 个月的项目结束时，原型设备将可供使用不仅适用于新冠肺炎患者，也适用于其他需要持续评估肺部状况的急诊科患者（细菌性肺炎、心源性水肿、透析）。我们的商业化方法是广泛许可这种简单的技术使具有广泛销售和分销能力的大型超声波制造商能够将技术带给用户。