Uterra by Illumigyn: A novel uterine manipulator for laparoscopic hysterectomies with an illuminated colpotomy cup

Abstract

Over 400,000 hysterectomies are performed annually in the U.S., and visibility limitations remain a leading challenge contributing to more surgical complications. The primary clinical challenge identified by stakeholders, including gynecologic surgeons, was the need for improved visualization during laparoscopic hysterectomies, particularly at the colpotomy incision site. Moreover, the market for uterine manipulators is projected to $696.46 million by 2031 with a 5.83% CAGR growth from 2024. Our mission at Illumigyn is to enhance surgical precision and safety in women’s health through ergonomic, illuminated technology designed by women, for women.
Key design specifications include maintaining the current curved rod of uterine manipulators and offering different-sized colpotomy cups, which allow the device to fit within the vagina and uterus. Additionally, a fiber optic cable will be threaded through the hollow handle, ending at the colpotomy cup, providing localized illumination on the colpotomy cup ring for procedure visibility. Our concept addresses surgeons’ needs by providing consistent, externally powered fiber-optic illumination directly at the surgical field, enhancing visibility without relying on battery longevity or internal light components. The transparent colpotomy cup rim enhances boundary visualization and reduces visual obstruction, facilitating safer incision planes and protecting nearby structures, such as the bladder and ureters.

Estimated production costs, including engineers, FDA fees, marketing, insurance, and manufacturing, are estimated at $578,923. The device sales to hospitals are estimated at $300 per device and $100 for a 3-pack of colpotomy cups.

Illumigyn’s entirely disposable uterine manipulator will be the only device to illuminate the entire colpotomy cup, adaptable to both laparoscopic and open abdominal uterine procedures. Our concept also eliminates the need for sterilization and reduces the risk of cross-contamination, aligning with hospital workflow efficiency priorities.

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