Advanced Intraoperative Imager for Nerve Identification

Project Summary/Abstract In this RandD program, Physical Sciences Inc. (PSI), in collaboration with Dartmouth Hitchcock Medical Center (DHMC), proposes to demonstrate and commercialize an advanced intraoperative fluorescence imager that can efficiently highlight nerve presence in the surgical bed and thus eliminate risk for nerve damage. Unintended nerve injury is a major cause of morbidity for many surgeries, especially in soft tissue orthopedic, otolaryngology, craniofacial, and genitourinary operations. Distinctive visualization of nerves from adjacent connective and fat tissues is challenging, and therefore nerve injury remains a major surgical complication. Fluorescence guided surgery (FGS) based on nerve-labelling agents has the potential to improve nerve identification. An outstanding problem in FGS is the negative impact of the strong ambient light, which interferes the weak fluorescence signal. Currently, this problem is mitigated by turning off the light in the operating room (OR) during the fluorescence imaging procedure. However, this causes unwanted interruption to the surgical workflow and thus dampens the enthusiasm of the surgeons and diminishes the potential for clinical adoption of FGS technologies. PSI and DHMC will develop a fluorescence imager that overcomes most of the issues of the current FGS systems. The proposed technology uses a novel tempo-spatially modulated (TSM) illumination scheme, which significantly reduces the negative impact of the ambient light background. During the Phase I effort, we successfully demonstrated a robust imager that is cable of suppressing the ambient light background by a factor of rt16,000. The high rate of background rejection enabled the collection of high-contrast nerve- highlighting images under the regular high-brightness OR light. During the Phase II program, we propose to further optimize and mature this technology and demonstrate its suitability and readiness for clinical use. The Phase II effort will focus on: 1) improving the technical performance by incorporating simultaneous dual-wavelength fluoresce and reflection white-light imaging; 2) demonstrating the benefits of the technology through extensive in vivo animal studies; 3) evaluating the clinical suitability and readiness of the imager; and 4) performing instrument demonstrations to key opinion leaders and outreach to potential customers. This RandD project will lead to a reliable solution for intraoperative fluorescence imaging in the presence of standard OR lighting conditions, avoiding the interruption to the normal surgical workflow by turning off the room light. This will promote intraoperative fluorescence imaging procedures to be seamlessly integrated into current clinical workflows for optimal patient outcome.