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.
