权益分类	功能权益	普通用户	{{item.name}}会员
{{category.name}}	{{benefitItem.name}}

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.

项目摘要根据最近来自世界各地的报告，需要不断评估肺水肿在危重病 COVID-19患者至关重要。胸部X光检查在疾病早期的敏感性降低; 病毒和运输低氧血症不稳定患者的风险使胸部CT成为疑似或确诊的COVID-19患者。肺部超声（LUS）是非电离和安全的，最近出现了一个有用的分流和监测工具，用于COVID-19患者的肺水肿量化。在 LUS，称为A线的成像伪影（平行于肺表面的周期性水平线，指示正常肺表面）通气模式）和B线（彗星状高回声区，表明肺泡或间质异常）进行评估。B线源于肺泡水肿区域内的声学混响，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的培训，并且即使如此，也高度依赖于操作员和机器。这部分是由于对B线形成的确切物理机制仍不完全了解。在这紧急关头我们建议对目前关于超声空化辅助药物递送到实体瘤的奖项进行竞争性修订以我们在剖析US成像伪影和超声仪器起源方面的专业知识为基础能够1）识别LUS中B线伪影的来源和特定的相关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者的时间，病毒暴露和辐射单个粘性LUSS元件将以特定方式附着在患者身上解剖位置类似于ECG导联，超声信号将被收集和处理，自动化算法，以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验证研究，以尽可能短的时间轴将器械快速投入临床，具体目标如下。在SA 1中，我们将对非COVID患者进行标准LUS检查，心源性肺水肿，同时收集原始RF信号数据，以了解B线的表现，原始射频信号和开发自动信号处理算法。在SA 2中，我们将设计和制造单- 元素LUSS原型，并验证自动信号处理算法对LUS成像在肺- 模仿海绵体模型在为期9个月的项目结束时，原型设备将准备投入使用不仅在COVID 19患者中，而且在其他艾德患者中，对肺部状况的持续评估是必不可少的（细菌性肺炎、心源性水肿、透析）。我们的商业化方法是广泛授权这种简单的技术，使大型超声波制造商与广泛的销售和分销能力，把技术带给用户。