A clinical platform for ultrasound-augmented laparoscopy

SUMMARY The overall objective of this project is to develop a clinical system that fuses laparoscopic video and laparoscopic ultrasound for enhanced visualization and navigation of laparoscopic procedures. Real- time video acquired using a laparoscope remains the primary visualization and guidance modality in over 14 million procedures performed per year globally, but it shows the operating surgeon organ surfaces only. Laparoscopic ultrasound can show internal structures, but is often displayed on a separate screen, leaving the surgeon to perform a mental integration of the 2 modalities. This task is inefficient, subjective, and variable with expertise. Introduction of a needle in the surgical field for ablative procedures further increases the surgeon's cognitive load by needing to register multiple sources of information for understanding three-dimensional spatial relationships and for maintaining hand-eye coordination. The proposed real-time data fusion, which we refer to as augmented reality (AR), presents complementary information to the operating team in an intuitive way. Research, development, and clinical translation efforts preceding this proposed project have demonstrated the technical feasibility and clinical utility of the proposed AR visualization and navigation. The team has successfully developed research prototypes and used the most recent prototype in 11 human cases at 2 different surgical centers. This proposal is borne out of the real-world lessons from our clinical translation experience toward building a clinical system. The major areas of improvement include reducing system complexity and size and improving reliability and clinical viability. Children's National Hospital and Terason will collaborate to develop custom specialized laparoscopic ultrasound transducers and offer AR as a well-integrated advanced application on a commercial ultrasound platform. The specific aims for this project are to 1) develop custom tracked laparoscopic ultrasound transducers, 2) develop a commercial-grade ultrasound system with integrated tracking and AR technologies, and 3) conduct preclinical evaluation of the developed system. Our scientific premise is that comprehensive intraoperative visualization of normal and pathological anatomy and navigated guidance of ablation needles will improve the precision, safety, and efficiency of prevailing laparoscopic procedures, and expand their utilization. The proposed academic-industrial partnership is designed such that these benefits are realized through the development of a clinical system ready for routine use in the operating rooms worldwide.