SBIR/STTR Award attributes
PROJECT SUMMARY/ABSTRACTAn estimated 40 million Americans suffer from chronic back pain, costing the US economy andgt;$250B/yr. Most chronic back pain originates in the facet joints, and can be treated by targeted joint injections, nerve blocks, and radiofrequency nerve ablation. However, the current standard of care relies on fluoroscopic needle guidance during these interventional procedures, leading to high cumulative radiation doses among members of this patient population, and limiting patient access to these procedures due to the infrastructure costs associated with performing fluoroscopically guided procedures. One result of limited patient access to interventional pain procedures is the ongoing reliance on long-term prescription opioid treatment for managing chronic pain conditions, despite the known hazards to patient wellbeing associated with prolonged opioid use.During this project, a 3D ultrasound-based, fluoroscopy-replacement imaging system will be developed under a quality management system (QMS) certified to ISO 13485:2016 and 21 CFR Part 820. The key technological innovations underpinning the development of this product include the following: 3D bone reconstruction technologies enabling ‘fluoroscopy-like’ renderings of the spine, an application-specific 3D ultrasound probe system to support real-time needle guidance to the facet joints, and automated visualization of the therapeutic injectate to confirm accurate administration of the drug. The primary technical tasks during the early stages of the project period include the execution of end-user clinical usability studies to guide technical specification development and implementation of core ultrasound visualization algorithms. Successful completion of these technical aims will result in the fabrication of pre-production systems for pre-clinical validation studies that will be conducted later in the project period.Pre-clinical product validation activities will include cadaver and human-imaging studies performed in collaboration with clinical experts who will verify that the system meets the requirements for the clinical application. The primary endpoint for the pre-clinical cadaveric studies is a direct measurement of the accuracy of needle placement to the facet joints, as confirmed by CT imaging. Additionally, a second pre-clinical study using cadaveric specimens will characterize the learning curve required to reach competency with the system by studying the needle placement accuracy achieved by 15 individual pain medicine physicians across multiple simulated procedures.Completion of this research project will result in the development and fabrication of a human clinical-trial- ready 3D ultrasound-imaging-based imaging system to support guidance of interventional procedures targeting the facet joints.PROJECT NARRATIVE Over 100 million people in the United States experience one or more chronic pain conditions, many of whom rely on targeted joint injections administered by interventional pain medicine services to provide prolonged pain relief. Expanding access to interventional pain medicine services is crucial for decreasing the use of long-term prescription opioid treatments for managing chronic pain, but the reliance on fluoroscopic imaging guidance significantly limits patient access to these interventional procedures and repeatedly exposes the patient population to harmful ionizing radiation. Therefore, the goal of this project is to develop and validate an ultrasound-based, fluoroscopy-replacement product that provides fluoroscopy-like visualization of spine anatomy, facilitates real-time needle guidance during interventional procedures performed in the spine, and increases patient access to non-opioid based therapies for alleviating symptoms associated with chronic pain.
