SBIR Phase II: OCT-Compatible Imaging Adaptor for Precision Vascular Access via Hollow-Bore Needles

这个SBIR第二阶段项目支持开发一种商业上可行的实时光学成像设备，以解决首次血管接入失败的问题。外周静脉通路(PIV)是所有年龄、种族和临床环境中最常见的侵入性手术。仅在美国，估计每年就有2.3亿人接受PIV。First Time IV Access的失败率高得惊人，高达35%-50%。多次尝试会导致痛苦和情绪困扰，特别是在失败率最高的儿科人群中。首次静脉注射的平均费用为69.76美元。三次或三次以上的尝试会使费用增加一倍，达到每静脉125美元以上。当无法获得PIV通道时，使用侵入性更大、风险更高、成本更高的中心静脉通道，这会增加血液传播感染和其他并发症的风险。一个中心静脉感染可增加7-20天的住院时间和56,000美元的额外(未报销)成本，每年增加多达23亿美元的美国重症监护病房成本。即使有超声波和近红外设备可用于改善首次静脉输液途径，这些失败率仍会发生。在第二阶段，项目组将改进为血管通路定制的混合光学相干断层扫描倾斜成像探头，并将其集成到商业上可行的系统中，以实现任何其他成像系统不支持的目标：发现和识别静脉；将血管导管针导向静脉；首次尝试获得腔内通路；以及确认腔内放置。该系统需要具有成本效益，耐用，并为众多不同的临床医生所接受。一次性适配器探头将连接到将触觉地使临床医生能够驱动光学探头的旋转和前进的手持件上，以获取创建临床相关3D实时图像所需的数据。数据被传输到控制单元进行处理，然后呈现在诸如智能手机的小型表格显示器上。研究活动将集中在开发在经济上可接受的手柄，该手柄不会干扰到静脉的可变角度方法。正在进行的研究的一个关键部分将集中在创建最佳图形用户界面(GUI)的软件设计上。手机、图形用户界面和视觉显示器的多种外形因素将由执业临床医生为最终产品进行评估。该奖项反映了NSF的法定使命，并已通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

This SBIR Phase II project supports development of a commercially viable real time optical imaging device to address the problem of failed first time vascular access. Peripheral IV access (PIV) is the most common invasive procedure for all ages, races and clinical settings. In the United States alone, there are an estimated 230 million PIVs placed per year. First time IV access has a shockingly high failure rate of 35%-50%. Multiple attempts result in pain and emotional distress, especially in the pediatric population where the failure rate is highest. The average cost of placing an IV on the first time is $69.76. Three or more attempts doubles the cost to be greater than $125 per IV. When PIV access cannot be obtained the more invasive, risky and costly central IV access is used which increases the risk of blood borne infections as well as other complications. One central IV sourced infection can add 7-20 additional days of hospital length of stay and $56,000 of additional (unreimbursed) cost, adding as much as $2.3 billion in increased US intensive care unit costs each year. These failure rates occur even though ultrasound and near infrared devices are available to improve first time IV access. In phase II, the project team will refine the hybrid Optical Coherence Tomography tipped imaging probe, customized for vascular access, and integrate it into a commercially viable system to fulfill goals not supported by any other imaging system: finding and recognizing veins; guiding the angiocath needle to the vein; acquiring intra lumen access on first attempt; and confirming intra lumen placement. The system needs to be cost effective, durable and acceptable to a multitude of diverse clinicians. The disposable adapter probe will connect to a hand piece that will tactilely enable the clinician to actuate rotation and advancement of the optical probe to acquire data necessary to create clinically relevant 3D real time images. The data are transmitted to a control unit for processing and then presented to a small form display such as smart phone. Research activity will be focused in developing the egonomically acceptable hand piece that does not interfere with variable angular approaches to the vein. A critical part of the ongoing research will focus on software design for creating an optimal graphic user interface (GUI). Multiple form factors of the hand piece, the GUI, and visual display will be evaluated by practicing clinicians for final production.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.