Development of a 2-dof uterine manipulator with LED illumination system as a new transvaginal uterus amputation device for gynecological surgeries.

ABSTRACT

BACKGROUND: Hysterectomy, the most common major gynecological operation worldwide, consists of removal of the uterus and can be performed abdominally, vaginally, or laparoscopically. A uterine manipulator is a key device used for uterine manipulation and cannulation in hysterectomies. The challenges of conventional manipulators are to move the uterus in two distinct planes and to identify cervical landmarks during circular cut and coagulation. MATERIAL AND METHODS: In this study, a structural synthesis of the two degrees of freedom parallel manipulator was performed considering the constraints noted by surgeons. Computer-aided design and assembly of the manipulator, the cervicovaginal cap with LEDs, and the external parts were performed before rapid prototyping. The final design of the uterine manipulator was then manufactured from stainless steel and tested on an artificial uterus model using a test chamber. RESULTS: This article presents the design, production and testing processes of an innovative manipulator with a motion capability up to 80° workspace both in the sagittal and coronal planes and an illumination system, easily detectable by the laparoscope, was successfully implemented on the manipulator's cervical cap in order to overcome the drawbacks of conventional uterine manipulators. CONCLUSIONS: Despite all the current studies and uterine manipulators on the market, no research has incorporated all the features mentioned above.