SBIR Phase I: Tactile sensing for spinal-needle placements

This SBIR Phase I project will develop an innovative imaging device that applies tactile sensing to the surface detection of vertebrae to help clinicians place needles for the nearly 13 million diagnostic and therapeutic spinal punctures performed in the United States each year. The standard of care involves manual palpation of the back to estimate a vertebral gap for needle insertion. This technique is highly inaccurate, often requiring multiple attempts, which lead to pain and complications, unpredictable procedure times, poor throughput, and high rates of referrals to radiology for fluoroscopic guidance. By offering an accurate means of localizing bony landmarks, this project will enable successful insertion in fewer attempts, thereby improving clinical outcomes and reducing costs across the $3.2 million market, including emergency medicine, neurology, anesthesiology, and pain medicine. The device can also be introduced for training and to reduce errors in clinical testing of intrathecal drugs; and can increase procedure access by offering an alternative, bedside solution for challenging cases. To date, tactile imaging has only been applied clinically to soft-tissue evaluations. This project will pave the way for expanded use of this low-cost, non-radiative modality; to possibly replace palpation for other procedures, such as joint injections and thoracenteses. The innovation is the first standalone, clinical tactile imager. Its imaging subsystem comprises a sensitive, high-resolution pressure-sensing array, which detects vertebral landmarks when pressed against the back, and communicates them as a 2D pressure map to an integrated display. The device also includes a novel needle guide, which allows for flexible and reliable insertion. Positive gap localization has been verified in early development. This project will first confirm accurate insertion relative to imaging output by characterizing the relationship between guide and visualized-landmark locations, and by developing a mechanism to stabilize the device over unpredictable lumbar curvatures. Next, 2D pressure information will be evolved into an optimally robust and intuitive image. Advanced algorithms will be developed to detect, track, and highlight features of interest; and to understand and predict device use across cases. At each stage, the device will be tested on phantoms and through IRB testing on anesthesiology patients. Performance will be evaluated across anatomical variations, and compared with the standard of care. The resulting device will have demonstrated feasibility as a comprehensive spinal-puncture localization and insertion solution, rendering it suitable for further development and testing toward a regulatory submission, and providing compelling evidence for continued optimization in Phase II. 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.