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

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10亿次插入 每年。在美国，每年销售超过3.5亿个外周静脉内（IV）导管，此外， 数百万条中央和动脉线路然而，外周静脉置管通常需要多次尝试， 插入，这是痛苦和耗时的。此外，早期失败率很高，可能导致 进一步并发症，包括外渗、血栓性静脉炎和筋膜室综合征，以及延迟 治疗药物的输送。超声引导的血管通路是广泛的，并且已经发展到 困难的IV通路成功率，但超声的成功率显然有改进的空间 引导的外周静脉放置停滞在80%。提高血管通路的成功率， 对病人护理和病人安全的巨大影响。 为了解决上述临床需求并克服当前的技术挑战，我们 开创了针头和成像系统之间"主动声学通信"的新概念， 指导我们正在进一步将这一概念发展成一种直观、易于使用、成本低的临床原型， 一次性使用，可与任何超声供应商配合使用，提供轻松的针尖跟踪，并区分组织 类型"5T（工具尖端跟踪+组织分型）-IV"引导平台将提供集成接口层， 临床医生，提供（1）高时空分辨率（亚毫米和亚秒）的工具尖端跟踪超过一个 宽视野，（2）编码对比度，闪烁主动回波脉冲，以可视化针尖，和（3） 在针尖处的高度准确的组织分型，以及（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， 在组织模仿幻影的性能表征，这将指导进一步迭代的形式- 因子和软件用户界面，包括在临床原型中进行动物试验。的疗效和 将通过执行人为因素研究，在临床前体模模型中广泛评价用户体验 65个终端用户。可量化的指标（例如，成功率、持续时间和试验次数）进行比较 传统US和5T-IV引导方法之间的差异将扩展到猪动物模型， 不同经验水平的颈静脉和股静脉插管（住院医师与主治麻醉师）。

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).