A novel transducer clip-on device to enable accessible and functional 3D ultrasound imaging

项目总结/摘要 三维超声成像（3D-US）是一种重要的临床工具，用于可视化、导航和 以3D方式真实的时间研究患者解剖结构和病理。由于其成本适中， 由于3D-US在放射治疗中的重要性，3D-US在诊断和干预的许多临床应用中发挥着重要作用。尽管 尽管3D-US具有显著的临床价值和潜力，但由于其目前的技术水平， 现有的3D-US解决方案受到许多限制的挑战，例如低成像速度、低分辨率、高分辨率和低分辨率。 功能性、不方便使用的笨重设备以及指定设备的高成本。几十年来， 长期以来，人们一直在寻求开发一种可访问的、功能性的和用户友好的3D-US 技术.在本提案中，我们将开发一种新的3D-US解决方案（称为FASTER）， 微制造的声反射器，以实现高速和高功能的3D-US成像。声学 反射器是可浸入水中的，并且封装在紧凑、重量轻且成本低的夹持装置中。它可以 可以容易地附接到不同类型的超声换能器和从不同类型的超声换能器移除， 超声波系统转换成3D与传统的3D-US技术（例如，摆动换能器和2D矩阵 阵列），FASTER不需要为不同的应用采购额外的超声换能器。 此外，FASTER实现了比传统3D-US高得多的成像容积率（高达1000 Hz 技术. FASTER与市场上的大多数超声系统兼容， 扫描仪到便携式和手持设备。在这个提案中，我们将进行基础技术开发， 研究并开展初步临床研究，为FASTER 3D-US奠定坚实的技术基础 技术.在目标1中，我们将专注于开发使用双轴反射器的Phase-1 FASTER设备 用于扩展成像容积率和视场（FOV）范围。我们还将把第一阶段更快地发展成 不需要外部设备并与超声波无线通信的独立设备 系统Aim 2将专注于开发FASTER的先进成像模式，包括3D血流成像 （3D-BFI）和3D剪切波弹性成像（3D-SWE）。将针对目标1和目标2开展初步临床研究。 2以促进FASTER设备和成像序列的开发和优化。在目标3中， 进行临床研究，以评价FASTER 3D-US在表征可疑腋窝方面的性能 乳腺癌患者的淋巴结（ALN）进行临床指示ALN活检。我们还将 评价FASTER在定位接受新辅助治疗患者的夹闭ALN中的性能 化疗这项研究的目的将由一个专家小组在超声成像，微传感器和 系统，医疗设备设计，以及来自伊利诺伊大学厄巴纳分校的乳腺癌- 尚潘，得克萨斯A&M大学，和马约诊所。

PROJECT SUMMARY/ABSTRACT Three-dimensional ultrasound imaging (3D-US) is an essential clinical tool for visualizing, navigating, and investigating patient anatomy and pathologies in real time in 3D. Owing to its moderate cost and lack of ionizing radiation, 3D-US plays an important role in many clinical applications for diagnosis and intervention. Despite the significant clinical value and potential, 3D-US is not a widely accessible and capable technology with its current implementations: existing 3D-US solutions are challenged by many limitations such as low imaging speed, low functionality, bulky devices that are inconvenient to use, and a high cost of designated equipment. For decades, there has been a long-standing quest for developing an accessible, functional, and user-friendly 3D-US technology. In this proposal, we will develop a new 3D-US solution (called FASTER) that uses a novel, fast-tilting microfabricated acoustic reflector to achieve high-speed and high-functionality 3D-US imaging. The acoustic reflector is water-immersible and enclosed in a clip-on device that is compact, lightweight, and low-cost. It can be easily attached to and removed from different types of ultrasound transducers to turn a conventional 2D ultrasound system into 3D. Unlike conventional 3D-US technologies (e.g., wobbler transducers and 2D matrix arrays), FASTER does not require the procurement of additional ultrasound transducers for different applications. Also, FASTER achieves a much higher imaging volume rate (up to 1000 Hz) than conventional 3D-US technologies. FASTER is compatible with most ultrasound systems on the market ranging from premium scanners to portable and handheld devices. In this proposal, we will conduct basic technology development research and carry out preliminary clinical studies to build a solid technical foundation for the FASTER 3D-US technology. In Aim 1 we will focus on developing the Phase-1 FASTER device that uses a double-axis reflector for extended range of imaging volume rate and field-of-view (FOV). We will also develop Phase-1 FASTER into a stand-alone device that does not need external equipment and communicates wirelessly with the ultrasound system. Aim 2 will focus on developing advanced imaging modes for FASTER, including 3D blood flow imaging (3D-BFI) and 3D shear wave elastography (3D-SWE). Pilot clinical studies will be conducted for both Aims 1 and 2 to facilitate the development and optimization of the FASTER device and imaging sequences. In Aim 3 we will conduct a clinical study to evaluate the performance of FASTER 3D-US in characterizing suspicious axillary lymph nodes (ALNs) for breast cancer patients undergoing clinically indicated biopsy of ALN. We will also evaluate the performance of FASTER in localizing clipped ALNs from patients undergoing neoadjuvant chemotherapy. The study aims will be carried out by a team of experts in ultrasound imaging, micro sensors and systems, medical device design, and breast cancer from the campuses of University of Illinois Urbana- Champaign, Texas A&M University, and Mayo Clinic.