SBIR/STTR Award attributes
Project Summary Laparoscopic surgeryreferred to as minimally invasive surgeryis a surgical technique in which operations in the abdominal or pelvic cavities are performed through smallmmincisionsIt is now considered the standard of care for many procedures on female pelvic floor which account for approximatelymillion cases per year in the U SThe laparoscopic technique includes traditional minimally invasive surgeryMISand robotic assisted surgeryRMISsystemsDuring a laparoscopic surgerythe video camera becomes a surgeonandapos s eyesas the surgeon uses the image from the video camera positioned inside the patientandapos s body to perform the procedureThe greatest limitation is the impairmentin the case of MISor complete lack of tactile sensationin the case of RMISand the absence of a simple and reliable tissue assessment toolThe aims of urogynecological surgery are to restore anatomybiomechanical integrity and functions of the female pelvic floorAgaina reliable and accurate tool for biomechanical soft tissue characterization in laparoscopic surgery is neededThe main goal of Phase I is to design and explorein development studya prototype of the Laparoscopic Tissue MonitorLTMbased on the acquisition of stress strain data by tactile and ultrasound transducers in urogynecological surgeryThe availability of stress strain data will allow real time computation of tissue elasticitystrain hardeninghysteresistissue heterogeneity and detection of a blood vesselThe main goal of Phase II is to conduct validation clinical studies with updated and certifiedprototype LTM devicesreport the clinical results to the FDA and define the regulatory strategyThe long term goal of the project is to bring into urogynecological surgery a compact and easy to use tool for soft tissue characterizationThe realtime fusion of a video stream from a laparoscope with the tissue parameters for a region of interest may increase surgical accuracysafetyas well as extend the technical capability of the laparoscopic surgery Project Narrative This project targets the development of a Laparoscopic Tissue Monitor for urogynecological surgeryIt will allow objective soft tissue characterizationelasticityblood vessel detectionwhich is currently missing in laparoscopyThe real time fusion of a video stream from a laparoscope with the tissue parameters for a region of interest may increase surgical accuracysafetyas well as extend the technical capability of the laparoscopic surgery
