SBIR-STTR Award

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.

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.