5T-IV: photoacoustic needle with beacon pulse for ultrasound guided vascular access with Tool-Tip Tracking and Tissue Typing

5T-IV：带有信标脉冲的光声针，用于通过工具提示跟踪和组织分型进行超声引导血管通路

• 批准号: 10677283
• 负责人: Emad M Boctor
• 金额: $ 38.01万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-15 至 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10677283
• 关键词: Acoustics; Address; Algorithms; Animal Model; Animals; Arterial Lines; Arteries; Back; Blood; Blood Vessels; Caliber; Cannulations; Cardiac Catheterization Procedures; Cardiac Surgery procedures; Catheters; Classification; Clinical; Communication; Compartment syndromes; Computer software; Consumption; Coupled; Data; Dedications; Development; Devices; Elements; Extracorporeal Membrane Oxygenation; Extravasation; Failure; Family suidae; Femoral vein; Femur; Fiber; Fiber Optics; Fire - disasters; Frequencies; Generations; Goals; Histocompatibility Testing; Human; Image; Injections; Interventional radiology; Intravenous; Intuition; Lasers; Legal patent; Life; Light; Limb structure; Link; Location; Medical; Methods; Monitor; Needles; Output; Pain; Patient Care; Patients; Pattern; Penetration; Performance; Peripheral; Pharmaceutical Preparations; Physiologic pulse; Positioning Attribute; Procedures; Puncture procedure; Resolution; Risk; Secure; Source; Structure; Surveys; System; Testing; Therapeutic; Thrombophlebitis; Time; Tissues; Ultrasonography; United States; Validation; Veins; Vendor; Venous; Visualization; Work; cost; deep learning; experience; experimental study; femoral artery; graphical user interface; image guided; imaging probe; imaging system; improved; in vivo; innovation; invention; manufacture; millimeter; novel; obese patients; optical fiber; patient safety; phantom model; point of care; pre-clinical; prototype; soft tissue; spatiotemporal; success; tool; transmission process; ultrasound; usability; virtual

Project Summary Vascular access is the most common medical procedure in the world, with over a billion insertions performed annually. In the United States, over 350-million peripheral intravenous (IV) catheters are sold yearly, in addition to millions of central and arterial lines. However, peripheral IV placement often requires several attempts at insertion, which is painful and time consuming. Furthermore, there is a high rate of early failure that can lead to further complications, including extravasation, thrombophlebitis, and compartment syndrome, as well as delays in delivery of therapeutic medications. Ultrasound guided vascular access is widespread and has advanced difficult IV access success rates, but there is clearly room for improvement as the success rate for ultrasound guided peripheral IV placement is stagnant at 80%. Improving the success rate for vascular access will have a huge impact on patient care and patient safety. To address the clinical need described above and overcome the current technical challenges, we have pioneered a novel concept of ‘active acoustic communication’ between needle and imaging systems for guidance. We are further evolving the concept into a clinical prototype that is intuitive and easy to use, low cost, disposable, works with any ultrasound vendor, offers easy needle tip tracking, and differentiates between tissue types. A ‘5T (tool tip tracking + tissue typing)-IV’ guidance platform will offer an integrated interface layer for clinicians, providing (1) high-spatiotemporal resolution (sub-millimeter and sub-second) tool tip tracking over a wide field-of-view, (2) encoded contrast with a flashing active echo pulse to visualize the needle tip, and (3) highly accurate tissue typing at the needle tip with (4) an unaltered clinical workflow. In this project, we will first develop a vendor-independent clinical prototype hardware and software package with comprehensive performance characterizations in tissue-mimicking phantoms, and this will guide further iteration of the form- factor and software user interface included in the clinical prototype to be tested in animals. The efficacy and user experience will be extensively evaluated in preclinical phantom models by performing human factor studies with 65 end users. Quantifiable metrics (e.g., success rate, time duration and number of trials) will be compared between conventional US and the 5T-IV guidance methods will be expanded to swine animal models for both jugular and femoral cannulation with different experience level (residents vs. attending anesthesiologists).

项目摘要 血管通道是世界上最常见的医疗程序，进行了超过十亿的插入 在美国，每年出售超过35亿静脉静脉（IV）导管，此外， 到数百万的中央和动脉线。但是，外围IV位置通常需要进行多次尝试 插入，这是痛苦且耗时的。此外，早期失败的率很高，可能导致 进一步的并发症，包括渗出，血栓质量和室综合征，以及延迟 在提供治疗药物方面。超声引导的血管通道很普遍，并且已提前 困难的IV访问成功率，但显然有改进的余地，因为超声波的成功率 指导的外围静脉输送放置停滞为80％。提高血管通道的成功率将具有 对患者护理和患者安全的巨大影响。 为了满足上述临床需求并克服当前的技术挑战，我们已经 开创了针线和成像系统之间“主动声通信”的新颖概念 指导。我们将该概念进一步发展为直观且易于使用的临床原型，低成本， 一次性，与任何超声供应商一起使用，提供易于针头跟踪，并在组织之间进行区分 类型。一个'5t（工具提示跟踪 +组织键入）-IV'指导平台将为集成接口层提供 临床医生，提供（1）高型时空分辨率（亚毫米和次秒）工具尖端跟踪 广泛的视野，（2）与闪烁的主动回声脉冲形成鲜明对比以可视化针尖，（3） 高度精确的组织在针头键入（4）不变的临床工作流程。在这个项目中，我们将首先 开发独立于供应商的临床原型硬件和软件包，并具有全面 模拟组织中的性能特征，这将指导形式的进一步迭代 要在动物中测试的临床原型中包含的因子和软件用户界面。效率和 通过进行人为因素研究，将在临床前幻像模型中广泛评估用户体验 有65个最终用户。将比较可量化的指标（例如，成功率，时间持续时间和试验数） 在常规美国和5T-IV指导方法之间，将扩展到两者的猪动物模型 具有不同经验水平的颈和股骨插管（居民与参加麻醉师）。