BME.13 Cervical Plug

• Anoushka Banerjee
• Jamie Rae Cuartero
• Lana Khadra
• Nicolle Scheurich
• Deepti Singh

Hysteroscopy is a minimally invasive procedure used to visualize the uterine cavity. It is the preferred method used to diagnose and treat irregular bleeding, infertility, lesions, removal of a foreign body, abnormal endometrial thickening, and other suspected uterine abnormalities. To perform the procedure, a hysteroscope is inserted through the patient’s cervix into the uterine cavity. Saline is pumped through the hysteroscope into the uterus to distend and better visualize the uterine walls. Hysteroscopes have a fixed diameter ranging from 0.5-0.7mm, and when the diameter of the cervix is larger than the hysteroscope, saline leaks back out through the cervix. This leakage prevents sufficient uterus distension, inhibiting proper visualization of the uterus, which in turn impedes the OB/GYN’s ability to accurately diagnose uterine abnormalities and create effective treatment plans for patients. For this reason, OB/GYNs need to control distention media (saline) deficit through the patient’s cervix during hysteroscopy to improve visualization of the uterus.

Our prototype consists of an adapter that slides onto the hysteroscope barrel and a balloon that inflates to seal cervixes from 1.2-3.0cm in diameter. To implement our idea into a physical prototype, we deconstructed and repurposed an endotracheal tube balloon and utilized 3D printing to create an adapter between the endotracheal tube and hysteroscope. Verification testing was performed to evaluate if our device ensures less than 50% saline leakage when subjected to saline pressures up to 80mmHg by inserting our device into a silicone cervix model and simulating pressures that our device would experience during a typical hysteroscopy. In comparison to control trials with no device, which leaked 100% of saline injected, saline leakage using our device remained below 50% for pressures ranging from 20-100mmHg. At our target pressure of 80mmHg, the average pressure used by OB/GYNs during hysteroscopy, saline leakage was 27.6%. The device was most successful at 20mmHg with a percent leakage of only 1.8%. By constructing a device meant to help OB/GYNs successfully operate on patients with varying cervix sizes, we aim to reduce the rate of premature termination of hysteroscopies, increase patient comfort, and help improve the standard of care for patients with female reproductive anatomy.