SBIR-STTR Award

The broader impact of this Small Business Innovation Research (SBIR) Phase I project is to improve the quality and efficiency of spinal access procedures by developing a needle guidance system that attaches to ultrasound machines. Lumbar punctures (LPs) are procedures used to diagnose and treat neurological conditions such as meningitis, multiple sclerosis and others. Without prompt intervention, meningitis infections can be fatal within days. During an LP, fluid must be collected from the center of the spine for diagnosis. The procedure can be challenging, costly, and time-consuming and is subject to practitioner experience and patient body type. Practitioners must manually feel for spinal landmarks at the skin surface to position the needle, then blindly insert into the spine. Up to 42% of procedures fail to access the target. In these cases, patients are referred to the Radiology department for an x-ray guided LP, which increases the cost of care, lengthens patient stay, and exposes the patient to radiation. The proposed research aims to develop a needle guidance system that enables spinal access procedures to be performed under real-time ultrasound imaging. By allowing providers to continuously monitor the needle?s trajectory, the proposed system can significantly improve first-attempt success rates.The proposed project aims to demonstrate the feasibility of a low-cost needle guidance system that interfaces with ultrasound equipment in bedside environments. Problems associated with LPs can be attributed to two primary causes: (1) the practitioner often cannot be certain of the target?s location and the needle?s trajectory; and (2) effective use of ultrasound imaging equipment as an alternative to the traditional blind technique relies on practitioner expertise in interpreting spinal ultrasound, which is rare in bedside settings. To remedy the first deficiency, the proposed system will consist of a needle-guiding attachment for an ultrasound probe and a software overlay that displays the needle?s trajectory on top of the ultrasound image. To address the barrier of ultrasound expertise, the software will also incorporate an anatomy recognition algorithm, displaying interpretable spine renderings corresponding to the imaged region. The proposed research will evaluate the needle trajectory prediction accuracy of the system in bench, cadaver, and live tissue models, ensuring minimal prediction error so the needle can consistently be guided to the target. Anatomy recognition software will be developed using images captured from the tissue models with the aim of correctly identifying important anatomical landmarks in at least 93% of cases.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.

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is to improve the quality and efficiency of bedside spinal access procedures by developing a needle guidance system that interfaces with existing ultrasound machines. Lumbar punctures (LPs) are performed to diagnose and treat neurological conditions such as meningitis. The traditional LP technique requires practitioners to manually feel for spinal landmarks to form a mental image of the anatomy before blindly inserting the needle into the spine, aiming for a small target containing spinal fluid. This methodology can be challenging, costly, and time-consuming and is highly dependent on practitioner experience and patient body type. Up to 42% of procedures fail to access the target. Failed cases require radiological intervention, increasing the cost of care, lengthening patient stay, and exposing patients to radiation. Hospitals in the United States lose an estimated $2 billion annually due to inefficiencies and failures in LPs. The proposed needle guidance system will enable bedside spinal access procedures to be performed under real-time ultrasound imaging, significantly improving first-attempt success rates. The guidance technology can further be applied in other clinical segments, improving the quality of care across a variety of needle-based procedures. This Small Business Innovation Research (SBIR) Phase II project aims to accomplish two primary objectives: 1) Complete development of a needle guidance system designed to interface with existing ultrasound machines; and 2) Develop an AI-powered anatomy detection software feature for the guidance system. These combined objectives will generate a functional, intuitive, and accessible solution that minimizes barriers to adoption while maximizing clinical and operational value. The proposed research involves conducting an array of safety and reliability studies to investigate the performance of the guidance system under realistic conditions. In developing a robust anatomy detection software feature, a spinal ultrasound data set will be created from a variety of non-patient volunteers. The data will be analyzed, processed, and used to train a machine learning model for anatomy detection. It is anticipated that the results of this project will demonstrate a sufficiently safe and efficacious system that can consistently guide a needle to an intended target with an error of less than 3 millimeters. The anatomy detection feature is expected to perform with at least 93% sensitivity and 85% specificity in identifying five key spinal landmarks; this level of performance would significantly reduce the knowledge barrier to performing ultrasound-guided interventions. 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.