OPTOSURGICAL LLC — Department of Health and Human Services STTR Phase I: 300

Description

Anastomotic leak (AL) is a serious complication of intestinal surgery, with many potential causes.This complication carries with it a reported mortality ranging from 6 to 39%. The best time toprevent a possible AL is during its creation in the operating room. A leak can occur due to atechnical error, but frequently it occurs as a consequence of poorly vascularized intestine.Creating a healthy and safe intestinal anastomosis requires a good blood supply to the two ends ofbowel to be joined. The tools for diagnosing well-perfused bowel intraoperatively are limitedand often rely on the subjective evaluation of the surgeon. This is problematic especially incircumstances in which the bowel appears to be andquot;duskyandquot; or threatened but not clearly necrotic. Thesurgeon can utilize serosal visualization and palpation of the mesenteric vessels, but this failsto evaluate the micro-perfusion of the intestine itself. In addition, most of the research onadoption of laparoscopic techniques in colorectal surgery shows increased rates of use (55.4% ofthe total of 309,816 patients who underwent elective colon resection between 2009 and 2012were performed minimally invasively). However, techniques using laparoscopic surgery orminimally invasive surgery (MIS) can be even less reliable for determining bowel viabilitydue to lack of gross palpation. In this research, we propose to develop a dye-free, multimodal laparoscopic imaging system for thequantitative assessment of bowel perfusion for precise surgical guidance duringlaparoscopic (and open) intestinal surgery. Optosurgical, LLC is a small business thathas established a strong partnership with researchers at Childrenandapos;s National Hospital,where expert clinicians and engineers will provide requisite clinical insight on thefull development, preclinical validation, and clinical translation of the proposed technologyfrom the bench to the operating room. The goal of this 1-year research proposal is to develop and evaluate the novel multimodal imagingcamera system for laparoscopic anastomosis through the following specific aims; Aim 1: To prototypethe multimodal camera system and integrate the system into a commercially availablelaparoscope; Aim 2: To validate the system pre-clinically in a swine model of in vivo intestinalischemia (n=12). Upon successful completion of this STTR Phase 1 project, we will proceed with the Phase 2 studies,wherein we will prepare a clinical grade device and execute animal studies using a swine model withstatistical validation, followed by a pilot clinical study on human subjects. This new opticalimaging technology holds great promise for evaluating bowel perfusion and potential intrinsicintestinal disorders with the goal of reducing postoperative morbidity/mortality and second-lookoperations for suspected intestinal leaks.Anastomotic leak (AL) is a dreaded complication of intestinal surgery, with many potential causes.We will develop a multimodal dye-free imaging camera system that will define and delineate bowelviability suitable for guiding intestinal resection and anastomosis during surgery. Thetechnology will be validated in large animal survival studies.