OPTOSURGICAL LLC — Department of Health and Human Services SBIR Phase I: NIBIB

Description

Postsurgical hypoparathyroidism or hypocalcemia are known to frequently occur after allthyroid surgeries due to misidentification and/or accidental disruption of the bloodsupply to the healthy parathyroid glands. Such accidental removal or injury of theparathyroid glands may lead to complications that result in lifelong sequelae. Because of thesmall size, variable position, and similar appearance to the surrounding tissues such as thelymph node, fat, and thyroid gland, it is often difficult for low-volume surgeons todistinguish the parathyroid glands from the thyroid tissue. Furthermore, blood supply tothe parathyroid glands is fragile and can be easily damaged during dissection. This is achallenging problem because it is clinically difficult to tell by visual inspection if a gland isstill viable after manipulation. Currently, there is no standardized or practicalequipment available to localize and assess the parathyroid gland viability in real timeand in a noninvasive manner during operation. Thus, any viable solution would be consideredsignificant to the endocrine community. In this study, to address these unmet clinical needs, we propose to develop a noninvasive, dual-sensor RGB/NIR handheld imager that will potentially be a paradigm changing tool for patients withthyroid tumors. Our imaging solution, called hANDY-i™, permits 1) noninvasive parathyroidgland identification and 2) seamless display of tissue viability in real time for thepreservation of the parathyroid glands during thyroid surgery. This research will be a jointeffort combining the technical and clinical expertise of Optosurgical LLC and Johns HopkinsHospital. To test this hypothesis, we will study the following specific aims: Aim1: Tocharacterize and deliver a compact, operating room-ready hANDY-i device; and Aim 2: Tovalidate hANDY-i to identify the parathyroid glands and assess viability in an early feasibilitystudy (N=10). Upon successful completion of this SBIR Phase I project, we will proceed to the Phase II project,wherein we will engineer a commercial-grade version of the hANDY-i device and execute large-scalemulticenter clinical trials. We envision that our technology will open a new door for the digitalimaging paradigm of dye-free, temporally unlimited, and quantitative tissue perfusion assessment.Successful translation of this technology will potentially reduce the risk ofhypoparathyroidism during thyroid surgery and improve clinical outcomes.Narrative The parathyroid glands are small tissues in the neck that play a key role in maintaining the calcium levels in the body. In thyroid surgery, serious complications such as postsurgical hypocalcemia (low calcium levels in the blood plasma) can occur when one or more parathyroid glands are unintentionally injured or removed because of their small size and appearance similar to that of the surrounding tissues. We propose to develop a portable, noninvasive camera to aid surgeons in effectively and safely preserving the parathyroid glands during operation, thus optimizing surgical decision-making and ultimately contributing to improved outcomes.