Very Low-Cost C-Scan Ultrasonic Imaging

描述（由申请人提供）：该项目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。利用超声成像直接可视化靶血管将最大限度地减少尝试和失败尝试的次数，从而允许更快速地进入血管以进行静脉输液或药物给药，提高患者满意度，减少对更具侵入性程序的需求，并节省医疗保健提供者的宝贵时间。该计划将通过开发和验证一种低成本（每单位2，000美元），易于使用和高度便携的超声成像系统（称为Sonic Window），使更多的医疗保健提供者可以在各种环境中使用超声引导血管通路。该系统在尺寸上与移动的电话或PDA相当，并且专门设计用于满足在医学成像方面经验很少或没有经验的用户的需求，其成本仅为当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（图像平面平行于皮肤表面），这对新手用户来说是直观的，并在采集部位显示这些图像，允许用户在透视图中看到图像，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一个低剖面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，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。本II期研究的具体目的是证明原型Sonic Window系统用于指导外周静脉穿刺程序的有效性。这一目标将通过2项涉及护士的临床研究来实现，这些研究比较了使用原型的超声引导外周静脉注射插入与基于标志的外周静脉注射插入（对照）的成功率。第一项研究将包括已知难以进入（即1次失败的进入尝试）需要IV置入的患者。第二项研究将包括需要从护理单位进行IV放置的患者，这些患者人群通常被认为难以进入（例如，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。这项研究的积极结论表明，外周静脉穿刺更快、更容易，这将增加人们对Sonic Window产品商业可行性的信心。在未来的开发阶段，我们将扩展这项工作，以包括更复杂的接入程序，如中心线插入。这项研究是PocketSonics，Inc.和弗吉尼亚大学（生物医学工程系，电气和计算机工程和护理学院）。该计划的目标是通过实现更快的进入和最大限度地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。通过超声成像直接可视化靶血管将最大限度地减少尝试次数和失败尝试次数，从而允许更快速的血管通路以进行静脉输液或药物给药，提高患者满意度，减少对更具侵入性程序的需求，并为医疗保健提供者节省宝贵的时间。该计划将通过开发一种低成本（每单位2，000美元），易于使用和高度便携的超声成像系统（称为Sonic Window），使更多的医疗保健提供者可以在各种环境中使用超声引导血管通路。

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.