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

SBIR 第一阶段：OCT 兼容成像适配器，通过空心针实现精确血管通路

• 批准号: 1746677
• 负责人: Thomas Mowery
• 金额: $ 22.5万
• 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: 2018
• 资助国家: 美国
• 起止时间: 2018-01-01 至 2018-08-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1746677&HistoricalAwards=false
• 关键词: SBIR; Phase; OCT; Compatible; Imaging

This SBIR Phase I project will develop a novel imaging adapter to temporarily integrate imaging into any needle or probe, enabling clinicians to visualize and identify anatomical markers in-situ, via real-time visualization, to improve vascular access without major modification of existing needles and technique. Venipuncture is the most common invasive procedure in medicine. Despite this, failure rates are 20-30% in easy access patients and 45-70% in difficult populations. Initial failed access leads to complications, increased hospital cost and poor patient outcomes. The proposed adapter represents a distinctive shift away from the way image guidance is currently used and several elements make this integrated, forward imaging system a transformative improvement: 1. It does not fundamentally change the standard procedural technique; 2. it improves image comprehension by ensuring the clinicians will always know what they are imaging (i.e. directly in front of the needle) drastically reducing complications caused by the needle penetrating the anatomy surrounding the target vessel, and; 3. The adapter will provide 10x better resolution than current imaging aids such as ultrasound. The proposed adapter will improve care of patients and significantly reduce healthcare costs by improving first time access success rates, reducing procedure complications, failures and escalations. Optical Coherence Tomography (OCT), is a recognized transformative imaging aid. Data suggests that integrated tip-sourced imaging with OCT drastically improves both patient safety and outcomes by allowing the physician real-time decision-making capabilities for minimally invasive procedures. However, there has been no commercially successful market penetration of forward looking needle-based OCT imaging technology. There are a number of reason for this: 1) the challenge of acquiring clinically relevant images; 2) the cost and the challenge of developing a system that economically puts OCT at the tip of a needle; and 3) the challenge of clinical usability. The project will address these concerns with the development of a disposable OCT-based imaging adapter. Five significant technical challenges will be addressed: ensuring correct placement of the probe at the tip of the needle after connection and advancement; incorporating scanning at the fiber tip in order to acquire two dimensional clinically relevant, forward facing images; determining the optimal angle of light projection from the probe; determining the optimal universal lens tip design for cost and ease of advancement through tissue; and lastly, integrating key research finding into a final probe design that will become the basis of the commercialized adapter. Solving these technical challenges will pave the way for FDA approval and subsequent commercialization of the device.

SBIR第一阶段项目将开发一种新型成像适配器，将成像临时集成到任何针头或探头中，使临床医生能够通过实时可视化原位可视化和识别解剖标记，以改善血管通路，而无需对现有针头和技术进行重大修改。静脉穿刺是医学上最常见的侵入性操作。尽管如此，在容易进入的患者中，失败率为20-30%，在困难人群中为45-70%。初始入路失败会导致并发症、增加住院费用和患者预后不良。所提出的适配器代表了与目前使用的图像引导方式不同的独特转变，并且几个元素使这种集成的前向成像系统成为一种变革性的改进：1.它不会从根本上改变标准程序技术; 2。它通过确保临床医生总是知道他们正在成像什么（即，直接在针的前面）来提高图像理解，从而大大减少了由针穿透目标血管周围的解剖结构引起的并发症，以及; 3.该适配器将提供比目前的成像辅助设备（如超声）高10倍的分辨率。申报适配器将通过提高首次入路成功率、减少手术并发症、失败和升级，改善患者护理并显著降低医疗成本。光学相干断层扫描（OCT）是公认的变革性成像辅助技术。数据表明，通过允许医生进行微创手术的实时决策能力，集成的尖端源成像与OCT大大提高了患者的安全性和结局。然而，前瞻性的基于针的OCT成像技术还没有商业上成功的市场渗透。这有许多原因：1）采集临床相关图像的挑战; 2）开发一种经济地将OCT置于针尖的系统的成本和挑战;以及3）临床可用性的挑战。该项目将通过开发一次性OCT成像适配器来解决这些问题。将解决五个重大的技术挑战：确保在连接和推进后探针在针尖处的正确放置;在光纤尖端处结合扫描，以获取二维临床相关的前向图像;确定来自探针的光投射的最佳角度;确定最佳通用透镜尖端设计，以降低成本并易于推进通过组织;最后，将关键的研究发现整合到最终的探针设计中，这将成为商业化适配器的基础。解决这些技术挑战将为FDA批准和随后的设备商业化铺平道路。