Research Project
9846752
Project Summary Laparoscopic surgery, referred to as minimally invasive surgery, is a surgical technique in which operations in the abdominal or pelvic cavities are performed through small (5-10 mm) incisions. It is now considered the standard of care for many procedures on female pelvic floor which account for approximately 1.6 million cases per year in the U.S. The laparoscopic technique includes traditional minimally invasive surgery (MIS) and robotic-assisted surgery (RMIS) systems. During a laparoscopic surgery, the video camera becomes a surgeon's eyes, as the surgeon uses the image from the video camera positioned inside the patient's body to perform the procedure. The greatest limitation is the impairment (in the case of MIS) or complete lack of tactile sensation (in the case of RMIS) and the absence of a simple and reliable tissue assessment tool. The aims of urogynecological surgery are to restore anatomy, biomechanical integrity and functions of the female pelvic floor. Again, a reliable and accurate tool for biomechanical soft tissue characterization in laparoscopic surgery is needed. The main goal of Phase I is to design and explore, in development study, a prototype of the Laparoscopic Tissue Monitor (LTM) based on the acquisition of stress-strain data by tactile and ultrasound transducers in urogynecological surgery. The availability of stress-strain data will allow real-time computation of tissue elasticity, strain hardening, hysteresis, tissue heterogeneity and detection of a blood vessel. The main goal of Phase II is to conduct validation clinical studies with updated and certified ?-prototype LTM devices, report the clinical results to the FDA and define the regulatory strategy. The long-term goal of the project is to bring into urogynecological surgery a compact and easy-to-use tool for soft tissue characterization. The real- time fusion of a video stream from a laparoscope with the tissue parameters for a region of interest may increase surgical accuracy, safety, as well as extend the technical capability of the laparoscopic surgery.
