Clear Guide Medical, Inc. SBIR Phase II Award, September 2022

Project Summary The objective of this proposal is to move into clinical practice the result of a preceding Phase I project, a compact instrument guidance system that allows physicians to see instruments advancing through an MRI volume without utilizing special needles, special headgear or calibration steps. MRI-guidance has been used for percutaneous needle injections to diagnose and treat neuropathic pain, perform needle biopsy, drainage, tumor ablation, and other clinical indications. In a pediatric setting, there is a preference for MR and ultrasound over CT and X-ray imaging because no ionizing radiation is emitted. Further, MR images are better for visualization of MSK soft tissue and bone lesions and would be preferred by clinicians but for the length of time to perform real-time needle insertions under MR guidance, and the poor ergonomics of in-bore insertions. Accurate and rapid diagnosis of bone tumors and other suspicious bone lesions in children is essential to appropriate clinical management. Bone biopsy procedures in children require higher targeting precision and accuracy due to their smaller sizes. MRI-guided bone biopsy is not routinely used because of current limitations in tools and technology. The “advance and check” technique whereby the needle trajectory is guided/monitored by intermediate scans has been translated from the CT environment, but this technique works well in the CT environment because of quick image acquisitions and short scanner bores. It is much more time consuming and much less convenient in the MRI environment. The overall objective of this Phase II effort is to adapt the technologies developed in the phase I to assist clinicians in accurate and fast image-guided instrument placement when using only MRI scans. The proposed navigation system for MRI-guided interventions will improve the standard of care by using computer vision and hardware advances to become a nearly hands-off companion device to the operator, automatically performing many steps which currently require user input. The LUMENA system projects the guidance feedback directly onto the intervention site as well as on a monitor. This approach allows the interventionalist to keep their focus on the insertion site instead of the monitor which is often not in front of them. The projected feedback is simple to follow and can be easily understood which makes the system intuitive with almost no learning curve. By making MRI-guided biopsies faster, the societal impact of the device is that it will allow more interventional procedures to be performed under MR-guidance, reducing ionizing radiation for patients and physicians alike.