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

这个SBIR第一阶段项目将开发一种新型的成像适配器，将成像暂时集成到任何针或探头中，使临床医生能够通过实时可视化在原位可视化和识别解剖标记，以改善血管通路，而无需对现有针和技术进行重大修改。静脉穿刺术是医学上最常见的侵入性操作。尽管如此，在容易接近的患者中，失败率为20%-30%，在困难人群中，失败率为45%-70%。最初的失败会导致并发症、增加医院成本和糟糕的患者结果。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显著转变，并且有几个因素使这种集成的、向前成像系统成为一种变革性的改进：1.它不从根本上改变标准的程序技术；2.它通过确保临床医生总是知道他们正在成像的东西(即，直接在针的前面)来提高图像理解能力，从而显著减少针穿过目标血管周围的解剖所引起的并发症；以及3.适配器将提供比目前的成像辅助设备(例如超声波)高10倍的分辨率。拟议的适配器将改善患者的护理，并通过提高首次访问成功率、减少程序并发症、失败和升级来显著降低医疗成本。光学相干层析成像(OCT)是公认的变革性成像辅助手段。数据表明，集成TIP来源的成像和OCT通过允许医生为微创手术提供实时决策能力，大大提高了患者的安全性和预后。然而，基于前瞻性针的OCT成像技术还没有在商业上成功地渗透到市场上。原因有很多：1)获取临床相关图像的挑战；2)开发一种将OCT经济地放在针尖的系统的成本和挑战；3)临床可用性的挑战。该项目将通过开发基于OCT的一次性成像适配器来解决这些问题。将解决五个重大技术挑战：确保在连接和推进后将探头正确放置在针尖；在光纤尖端结合扫描以获取临床相关的二维正面图像；确定探头的最佳投射角度；确定最佳通用透镜尖端设计，以降低成本并便于通过组织推进；最后，将关键研究成果整合到最终的探头设计中，该设计将成为商业化适配器的基础。解决这些技术挑战将为FDA的批准和随后的设备商业化铺平道路。

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.