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 血管通路是世界上最常见的医疗程序，进行了超过10亿次的插入 每年一次。在美国，每年售出超过3.5亿根外周静脉(IV)导管 数以百万计的中央动脉和动脉。然而，外周静脉置入通常需要多次尝试 插入，这是痛苦和耗时的。此外，早期失败率很高，可能会导致 进一步的并发症，包括渗出、血栓性静脉炎和间隔综合征，以及延误 在提供治疗性药物方面。超声引导的血管通路很普遍，而且已经取得了进展 困难的静脉注射成功率，但作为超声的成功率，显然还有改进的空间 导引下的外周静脉置入停滞在80%。提高血管通路的成功率将有一个 对患者护理和患者安全产生巨大影响。 为了满足上述临床需求并克服当前的技术挑战，我们已经 首创针头和成像系统之间的“主动声学通信”的新概念 指导。我们正在将这一概念进一步演变为一种临床原型，它直观易用，成本低， 一次性，适用于任何超声波供应商，提供轻松的针尖跟踪，并区分组织 类型。5T(刀尖追踪+组织分型)-IV引导平台将为以下方面提供集成接口层 临床医生，提供(1)高时空分辨率(亚毫米和亚秒)工具提示跟踪 宽视场，(2)用闪烁的主动回波脉冲编码对比度，以可视化针尖，以及(3) 针尖高度准确的组织分型，(4)不改变临床工作流程。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， 在模拟组织模型中的性能表征，这将指导形式的进一步迭代- 将在动物身上进行测试的临床原型中包含的因素和软件用户界面。有效率和 将通过执行人类因素研究，在临床前幻影模型中广泛评估用户体验 拥有65个最终用户。将比较可量化的指标(例如成功率、持续时间和试验次数) 在常规US和5T-IV之间的指导方法将扩展到两者的猪动物模型 不同经验水平的颈静脉插管和股动脉插管(住院医师与主治麻醉师)。