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

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.