The overall objective of the proposed research is to develop and conduct clinical translation of a novel visualization technology that provides minimally invasive surgeons the ability to visualize normally invisible internal anatomy together with organ surfaces. The technology addresses a long-standing need in minimally invasive laparoscopic surgery to see inside and around a structure before dissecting, a need that currently used laparoscopes, even when high-definition and stereoscopic, cannot meet. We plan to achieve our objective by integrating 2 real-time surgical imaging modalities: (1) real-time laparoscopic video that shows the surface view, and (2) laparoscopic ultrasound capable of visualizing internal structures. We call the resulting visualization capability augmented reality (AR), in which laparoscopic video (the reality) is augmented with ultrasound findings, especially the tumors and the blood vessels. Children's National Medical Center and IGI Technologies combined their complementary expertise in Phase I to demonstrate the technical feasibility of a compact, accurate and clinically viable AR visualization system, based on electromagnetic (EM) tracking. The two performance milestones, pertaining to system's registration accuracy and interactivity, were met. We now propose developing a fully integrated, clinical system and performing its preclinical and clinical evaluation in Phase II. To perform a thorough evaluation of the technology and to cater to the entire surgical market (necessary for commercial success), we have expanded the partnership to include an adult surgical center in University of Pittsburgh Medical Center. Overall, the specific aims of the proposed research are to (1) convert the EM tracking-based Phase I prototype to a clinical AR visualization system, (2) evaluate the system performance through animal studies, and (3) conduct preliminary clinical demonstration of AR visualization.
These aims are designed to fully develop a clinical AR visualization system and then conduct its preclinical and clinical demonstration and validation. The Phase II results should allow us to obtain investigational device exemption designation from the FDA for multi-center clinical trials in a follow-on phase. Successful completion of the proposed research will create a smart surgical visualization system that promises to provide surgeons greater confidence, minimize complications, shorten procedure times, reduce blood loss, and help expand the utilization of minimally invasive surgeries to beyond their current share of all surgeries. The anticipated benefits will apply equally to pediatric and adult surgery.
Minimally invasive surgeons are limited to a surface view of the surgical anatomy as provided by real- time video. This project will develop and conduct clinical translation of an enhanced surgical visualization technique that will also show hidden structures such as tumors and blood vessels below the organ surfaces. This new visualization technique has the potential to give surgeons greater confidence, minimize complications, shorten procedure times, reduce blood loss, and expand the range of minimally invasive surgeries.
