Very Low-Cost C-Scan Ultrasonic Imaging

描述(由申请人提供)：该计划的目标是通过实现更快的血管访问和最大限度地减少失败的尝试来拯救生命并提高需要血管访问的人的护理质量。通过超声成像直接显示目标血管将最大限度地减少尝试和失败的次数，从而使静脉输液或药物的注射能够更快地进入血管，提高患者满意度，减少对更具侵入性的程序的需求，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名为Sonic Window的低成本(每台2,000美元)、易于使用和高度便携的超声成像系统，使更多的医疗保健提供者可以在广泛的环境中使用超声引导血管。该系统的大小将可与移动电话或PDA相媲美，专为满足在医学成像方面几乎没有经验的用户的需求而设计，成本仅为目前可用的便携式超声系统的一小部分。我们的系统将形成对新手用户直观的C扫描图像(图像平面与皮肤表面平行)，并在采集现场显示这些图像，允许用户以透视图像的方式查看图像，如果您有一个透过皮肤进入感兴趣组织或血管的清晰窗口，则可以获得该图像。Sonic Window是通过结合低调2D阵列、定制集成电路、在商用数字信号处理器上实现的新颖波束形成和图像处理算法以及LCD显示器来实现的。创新的技术方法被用来绕过传统的工程学观点，即C扫描成像固有地比B扫描成像(垂直于皮肤表面的平面)更复杂和昂贵。这项第二阶段研究的具体目的是证明一个原型Sonic Window系统在指导外周静脉通路程序方面的有效性。这一目标将通过两项涉及护士的临床研究来实现，这些研究将超声引导的外周静脉置入的成功率与原型和具有里程碑意义的外周静脉置入(对照)进行比较。第一项研究将包括已知的难以进入的患者(即1次失败的进入尝试)，需要静脉置入。第二项研究将包括需要从护理单元静脉注射的患者，这些患者通常被认为难以进入(例如，咖啡科、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。这项研究得出了积极的结论，证明了更快、更容易地进入外围静脉输液，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，如中线插入。这项研究是PocketSonics公司和弗吉尼亚大学(生物医学工程系、电气系和计算机工程系)的合作成果。和护理学院)。该计划的目标是通过实现更快的血管访问和最大限度地减少失败的尝试，来拯救生命并提高需要血管访问的人的护理质量。通过超声成像直接显示目标血管将最大限度地减少尝试和失败的次数，从而使静脉输液或药物的注射能够更快地进入血管，提高患者满意度，减少对更具侵入性的程序的需求，并节省医疗保健提供者的宝贵时间。该计划将通过开发一种名为Sonic Window的低成本(每台2,000美元)、易于使用和高度便携的超声波成像系统，使更多的医疗保健提供者在广泛的环境中获得超声引导的血管通道。

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.