Research Project
9466211
Project Summary This project will develop new 3D visualization to improve stent-graft deployment during minimally-invasive endovascular aortic repair (EVAR) by overcoming limitations of 2D x-ray fluoroscopy (?fluoro?). 3D holographic guidance, navigation and control (3D GN&C) will be provided to decrease fluoro radiation dose burden to patients and OR staff during treatment of aortic aneurysms, particularly when deploying stent-grafts within hostile aortic anatomy, with challenges such as short and/or angled landing zones. Radiation-free 3D GN&C that is not limited by a 2D display will enable accurate stent-graft positioning with less irradiation, and thus fewer postoperative complications or need for re-intervention. This innovation will also expand the patient population eligible for EVAR, particularly those with highly unfavorable aortic anatomy, as the demand and utilization of the minimally-invasive approach continues to rise. 3D GN&C for EVAR will be developed and integrated with our computer-assisted surgical platform, the Intra- Operative Positioning System (IOPS). The Guidance subsystem digitally augments the surgical field novel with holographic representations of the virtual stent-graft deployment device within a patient-specific digital aortic model for targeting the aneurysm's landing zone using a modern, self-contained augmented/mixed reality headset. Navigation uses innovative methods to accurately track in real-time the 3D position and orientation of present and next-generation stent-graft delivery devices as well as sensor-coil-equipped wires and catheters in a low-level, safe electromagnetic (EM) field. Control indicators, based on EM tracking data and the guidance plan, also augment the aorta and stent-graft digital models to suggest maneuvers of the delivery device as it approaches the aneurysm?s proximal neck landing zone. The feasibility criteria are to demonstrate that 3D GN&C can be used to decrease fluoro radiation dose while accurately deploying EVAR stent-grafts within challenging aneurysm anatomy using state-of-the art delivery devices. The Specific Aims include evaluation of GN&C usability with a standard scale, a bench study to verify accurate stent-graft deployment within 3D-printed complex aortic morphology, and a preclinical porcine study to prove that, at this stage of R/R&D, 3D GN&C used as an adjunct to fluoro can decrease fluoro radiation dose relative to fluoro alone, with comparable stent-graft deployment accuracy and procedure time. Meeting all acceptance criteria of the Specific Aims will lead to a future clinical study in STTR Phase 2 to demonstrate safety, effectiveness, and efficiency of stent-graft deployment using 3D GN&C. Improved stent- graft placement and overcoming limitations of fluoro will pave the way to realizing the full clinical and economic benefits of EVAR over highly invasive open surgical repair. The ultimate reach goes beyond aneurysmal disease to include aortic dissection, additional endovascular procedures, and other minimally invasive applications to further benefit a broader population of patients and caregivers as well as global healthcare.
