N.4 Amelioration of the risk for uterine perforation during entry into the uterine cavity at the time of hysteroscopy 

Title: Amelioration of the risk for uterine perforation during entry into the uterine cavity at the time of hysteroscopy

Hysteroscopy is a commonly performed minimally invasive gynecological procedure. During hysteroscopy, a camera with an operating channel is inserted through the cervix and into the uterus in order to diagnose and treat a variety of uterine pathologies. Often, the most difficult portion of the procedure is successfully navigating the passageway within the cervix in order to access the uterus. This passageway is often narrow, stenotic or tortuous. Difficulty traversing the cervix can lead to several complications including the formation of “false passageways” which preclude performance of the scheduled procedure, or more dangerously, “uterine perforation” which can result in injury to the patient’s bowel or bladder or rectum. In 1879 Hagar dilators, rigid metal probes of increasing diameter, were invented to gain access to the uterine cavity. There have been several variations to the Hagar dilator but no real, successful, innovation within the field.

Thus, the clinical gap is lack of a uterine access/dilating device that solves several deficiencies in the existing devices used for hysteroscopy.