Very Low-Cost C-Scan Ultrasonic Imaging

描述（由申请人提供）：该计划的目标是通过更快的进入和尽量减少失败的尝试来挽救生命并提高需要血管进入的人的护理质量。利用超声成像直接可视化目标血管将最大限度地减少尝试和失败的尝试次数，从而允许更快速地进入血管进行静脉输液或药物治疗，提高患者满意度，减少对更具侵入性的手术的需求，并节省医疗保健提供者的宝贵时间。该项目将通过开发和验证一种低成本（每台2000美元）、易于使用、高度便携的超声波成像系统“声波窗口”，使超声引导血管进入更多的医疗保健提供者。该系统的尺寸将与移动电话或PDA相当，专门设计用于满足很少或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。我们的系统将形成c扫描图像（与皮肤表面平行的图像平面），对新手用户来说是直观的，并在获取的位置显示这些图像，允许用户从透视的角度看到图像，如果你有一个清晰的“窗口”通过皮肤进入感兴趣的组织或血管。声波窗口是通过结合低轮廓二维阵列、定制集成电路、新型波束形成和图像处理算法实现的商业数字信号处理器，以及LCD显示器来实现的。采用创新的技术方法来规避传统的工程智慧，即认为c扫描成像本质上比b扫描成像（垂直于皮肤表面的平面）更复杂和昂贵。这个第二阶段研究的具体目的是证明一个原型声波窗口系统在指导外周静脉通路过程中的功效。这一目标将通过两项涉及护士的临床研究来实现，这两项研究将超声引导外周静脉注射的成功与原型与基于地标的外周静脉注射（对照组）进行比较。第一项研究将包括已知难以接触需要静脉滴注的患者（即1次接触失败）。第二项研究将由需要静脉滴注的患者组成，这些患者来自通常被认为难以进入的护理单位（如减肥科、肿瘤科、ICU）。为了进行研究，我们将首先完成临床Sonic Window原型的集成，并进行系统验证、优化和安全性验证。从这项研究中得出的积极结论，证明了更快、更容易的外周静脉注射，将增加对Sonic Window产品商业可行性的信心。在未来的发展阶段，我们将扩展这项工作，包括更复杂的访问程序，如中心静脉插入。这项研究是pocketsonic公司和弗吉尼亚大学生物医学工程系的合作成果。电气与计算机工程和护理学院)。该计划的目标是通过更快的进入和尽量减少失败的尝试来挽救生命并提高需要血管进入的人的护理质量。利用超声成像直接可视化目标血管将最大限度地减少尝试和失败的尝试次数，从而允许更快速地进入血管进行静脉输液或药物治疗，提高患者满意度，减少对更具侵入性的手术的需求，并节省医疗保健提供者的宝贵时间。该项目将通过开发一种低成本（每台2000美元）、易于使用、高度便携的超声波成像系统“声波窗口”，使超声引导血管进入更多的医疗保健提供者。

DESCRIPTION (provided by applicant): The goal of this program is to save lives and improve the quality of care of people requiring vascular access by enabling quicker access and minimizing failed attempts. Direct visualization of target vessels with ultrasound imaging will minimize number of attempts and failed attempts, thus allowing more rapid vascular access for administration of IV fluids or medications, improving patient satisfaction, reducing the need for more invasive procedures and saving healthcare providers' valuable time. This program will make ultrasound guided vascular access available to a greater number of healthcare providers in a wide range of settings by developing and validating a low-cost ($2,000 per unit), easy to use, and highly portable ultrasonic imaging system called the Sonic Window. This system will be comparable in size to a mobile phone or PDA and is specifically designed to meet the needs of users with little or no experience in medical imaging at a fraction of the cost of currently available portable ultrasound systems. Our system will form C-Scan images (image plane parallel to skin surface) that are intuitive for novice users and display those images at the site of acquisition, allowing 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 imaging is inherently more complex and costly than B-Scan imaging (plane perpendicular to skin surface). The Specific Aim of this Phase II research is to demonstrate the efficacy of a prototype Sonic Window system for guiding peripheral IV access procedures. This aim will be accomplished through 2 clinical studies involving nurses which compare the success of ultrasound guided peripheral IV insertions with the prototype to landmark based peripheral IV insertions (control). The first study will be comprised of known difficult to access patients (i.e. 1 failed access attempt) requiring IV placement. The second study will be comprised of patients requiring IV placement from a nursing unit with a population of patients generally regarded to have difficult access (e.g. bariatrics, oncology, ICU). In order to perform the studies, we will first complete integration of a clinical Sonic Window prototype and perform system validation, optimization and safety verification. A positive conclusion from this research, demonstrating faster and easier peripheral IV access, will increase confidence in the commercial viability of the Sonic Window product. In future stages of development, we will extend this work to include 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., Electrical and Computer Eng. and the School of Nursing). The goal of this program is to save lives and improve the quality of care of people requiring vascular access by enabling quicker access and minimizing failed attempts. Direct visualization of target vessels with ultrasound imaging will minimize number of attempts and failed attempts, thus allowing more rapid vascular access for administration of IV fluids or medications, improving patient satisfaction, reducing the need for more invasive procedures and saving healthcare providers valuable time. This program will make ultrasound guided vascular access available to a greater number of healthcare providers in a wide range of settings by developing a low-cost ($2,000 per unit), easy to use, and highly portable ultrasonic imaging system called the Sonic Window.