SBIR/STTR Award attributes
PROJECT SUMMARY Every year, neurologists and emergency personnel perform over 400,000 diagnostic and therapeutic lumbar punctures (LP) to collect cerebrospinal fluid (CSF), a vital fluid in the diagnosis and treatment of a myriad of neurological diseases and disorders. Under standard care, LPs are performed in an inpatient environment at the bedside. The procedure involves navigating a needle that can be up to 14 cm in length into a 3-6 mm target window in the lumbar spine region. Physicians face the challenge of precise, accurate navigation and placement of the needle to the target. Failure to collect a viable sample and procedure-related complications can lead to misdiagnoses, treatment delays, and unnecessary and even dangerous procedures. Currently, the average physician takes 3 attempts to correctly place the needle. The associated failure rate of the procedure is ~23.3%. The failure rate rises to 50% in obese and scoliotic patients, for which the physician must navigate through excess adipose tissue and difficult anatomy. Failure to collect CSF leads the use of fluoroscopic guidance, which takes longer and subjects the patient and physician to ionizing radiation. Except for fluoroscopic guidance, the current standard of care does not involve any visualization of tissue using technology such as topical ultrasound. In this phase I application, we propose a navigation system featuring a patient-anchored ultrasound patch which transforms LPs from a blind procedure with high failure rate to a fast and simple one. Our solution addresses the typical shortcomings of regular ultrasound guidance which has limited its wide adoption for LPs. The patch ultrasound relieves the clinician from handling the ultrasound and needle simultaneously, yields high-contrast images of the vertebrae pathway, and provides a reliable 3D volume. The navigation system with augmented reality helps the clinician to successfully reach the target on the first try. Most importantly, the combination of these technologies offers what we call active needle visualization, where the imaging plane of the ultrasound is controlled to provide an optimal view of the needle in a closed-loop system. Our hypothesis in this proposal is that the simplicity of the patch design and the availability of off-the-shelf navigation components combined with Clear Guide’s matured navigation platform promises a cost-effective solution suitable for the clinical application at hand. We will achieve our goal through the following aims: (1) Develop and Integrate Patient-anchored Ultrasound Imaging Patch with Clear Guide Medical Tracking System, (2) Interface Design and Incorporation into a Tablet and head-mounted display (HMD), and (3) Accuracy Measurement and User Data Collection. The ultimate goal of this academic (Johns Hopkins University) and industry (Clear Guide Medical) collaboration is the safe, economic, and effective development of patient-anchored ultrasound patch to actively guide LP procedures.PROJECT NARRATIVE Every year, neurologists and emergency personnel perform over 400,000 diagnostic and therapeutic lumbar punctures to collect cerebrospinal fluid, a vital fluid in the diagnosis and treatment of a myriad of neurological diseases and disorders. The associated failure rate of the procedure is approximately 23% and the failure rate rises to 50% in obese and scoliotic patients. Our goal is to develop a cost-effective patient-anchored ultrasound patch with navigation system, which transforms lumbar punctures from a blind procedure with high failure rate to a fast and simple one.
