Portable C-scan Ultrasound for Rapid Vascular Access

描述（由申请人提供）：本研究和开发的目标是通过实现更快的通路和最大限度地减少失败尝试来挽救生命并提高需要血管通路的患者的护理质量。在许多情况下，实现快速血管通路至关重要，因为快速静脉输液或药物给药可能会改变患者结局。该第一阶段提案寻求资金，以支持开发一种低成本（每台<2，000美元），易于使用和高度便携的C扫描超声成像系统，称为Sonic Window。该系统的尺寸与移动的电话或PDA相当，旨在满足没有医学成像经验的用户的需求，其成本仅为目前可用的便携式超声系统的一小部分。C扫描格式与传感器上集成的紧凑型显示器相结合，使用户能够在透视图中看到图像，如果您有一个清晰的"窗口"穿过皮肤进入感兴趣的组织或血管，则可以获得该透视图。声波窗口是通过结合低剖面2D阵列，定制集成电路，新的波束形成和图像处理算法实现的商业数字信号处理器和LCD显示器。采用创新的技术方法来规避传统的工程智慧，传统的工程智慧认为C扫描（图像平面平行于皮肤表面）成像本质上比B扫描成像（平面垂直于皮肤表面）更复杂和昂贵。本I期研究的具体目的是测试以下假设：C扫描图像格式和与探头集成的显示器将使超声新手用户更容易、更快地执行超声引导血管通路手术。将使用无生命超声模型的研究来检验该假设，在该研究中，医护人员使用Sonic Window系统引导快速外周静脉穿刺。这些程序将直接与设计用于血管通路应用的最先进商业B-Scan便携式超声系统引导的程序进行比较。本研究选择护理人员，因为他们之前没有大量接触过超声，但接受过外周静脉导管插入术的培训。在本研究开始之前，我们将完成原型Sonic Window系统的集成，并进行系统验证和优化。这项研究的积极结论表明，该原型更快，更容易使用，将为Sonic Window产品的商业可行性提供更大的信心。在未来的开发阶段，我们将扩展这项工作，以包括人类研究，并证明声波窗的有效性，指导更复杂的接入程序，如中心线插入。这项研究是PocketSonics，Inc.以及弗吉尼亚大学生物医学工程系和电气与计算机工程系。

DESCRIPTION (provided by applicant): The goal of this research and development is to save lives and improve quality of care of people requiring vascular access by enabling quicker access and minimizing failed attempts. Achieving rapid vascular access is critical in many cases where rapid administration of IV fluids or medications can alter patient outcomes. This Phase I proposal seeks funding to support the development of a low-cost (<$2,000 per unit), easy to use, and highly portable C-Scan ultrasonic imaging system called the Sonic Window. This system will be comparable in size to a mobile phone or PDA and is designed to meet the needs of users with no experience in medical imaging at a fraction of the cost of currently available portable ultrasound systems. The C-scan format combined with the compact display integrated at the transducer allows the user to see the image in the perspective that would be obtained if you had a clear 'window' through the skin into the tissue or vessel of interest. The Sonic Window is being realized by combining a low profile 2D array, custom integrated circuits, novel beamforming and image processing algorithms implemented on a commercial Digital Signal Processor and a LCD display. Innovative technological approaches are employed to circumvent conventional engineering wisdom that holds that C-Scan (image plane parallel to skin surface) imaging is inherently more complex and costly than B-Scan imaging (plane perpendicular to skin surface). The specific aim of this Phase I research is to test the hypothesis that the C-scan image format and the display integrated with the transducer will make it easier and faster for novice ultrasound users to perform ultrasound-guided vascular access procedures. This hypothesis will be tested using a study with an inanimate ultrasound model in which paramedics use the Sonic Window system for guiding rapid peripheral IV access. These procedures will be compared directly to those guided by a state-of-the-art commercial B- Scan portable ultrasound system designed for vascular access applications. Paramedics are chosen for this study because they do not have significant prior exposure to the use of ultrasound but are trained in obtaining peripheral IV catheterization. Before this study can begin, we will complete integration of the prototype Sonic Window system and perform system validation and optimization. A positive conclusion from this study, demonstrating that this prototype is faster and easier to use, will provide increased confidence in the commercial feasibility for the Sonic Window product. In future stages of development, we will extend this work to include human studies as well as demonstrate the effectiveness of the Sonic Window for guiding more complicated access procedures such as central line insertions. This research is a collaborative effort between PocketSonics, Inc. and the University of Virginia Departments of Biomedical Eng. and Electrical and Computer Eng.