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

SBIR 第二阶段：OCT 兼容成像适配器，通过空心针实现精确血管通路

• 批准号: 1853242
• 负责人: Thomas Mowery
• 金额: $ 74.78万
• 依托单位: WestFace Medical Device
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-04-01 至 2022-09-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1853242&HistoricalAwards=false
• 关键词: SBIR; Phase; II; OCT; Compatible

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.

该SBIR II期项目支持开发商业上可行的真实的时间光学成像设备，以解决首次血管通路失败的问题。 外周静脉穿刺（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2.3亿个PIV。第一次静脉注射的失败率高达35%-50%。 多次尝试会导致疼痛和情绪困扰，特别是在失败率最高的儿科人群中。第一次放置IV的平均成本为69.76美元。 三次或三次以上的尝试使成本增加一倍，每IV超过125美元。当无法获得PIV通路时，使用更具侵入性、风险更高且成本更高的中心IV通路，这增加了血液传播感染以及其他并发症的风险。一次中心静脉源性感染可增加7-20天的住院时间和56，000美元的额外（未报销）费用，每年增加多达23亿美元的美国重症监护病房费用。 即使超声和近红外设备可用于改善首次IV访问，这些故障率也会发生。在第二阶段，项目团队将改进为血管通路定制的混合光学相干断层扫描尖端成像探头，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都不支持的目标：发现和识别静脉;将angiocath针引导到静脉;在首次尝试时获取腔内通路;并确认腔内放置。 该系统需要具有成本效益，耐用，可接受的众多不同的临床医生。一次性适配器探头将连接到手持件，手持件将使临床医生能够驱动光学探头的旋转和推进，以采集创建临床相关的3D真实的时间图像所需的数据。 数据被传输到控制单元进行处理，然后呈现给小型显示器，如智能手机。研究活动将集中于开发符合人体工程学要求的手柄，该手柄不会干扰静脉的可变角度入路。正在进行的研究的一个关键部分将集中在软件设计，以创建一个最佳的图形用户界面（GUI）。该奖项反映了NSF的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。