College - Author 1
College of Engineering
Department - Author 1
Biomedical Engineering Department
Degree Name - Author 1
BS in Biomedical Engineering
College - Author 2
College of Engineering
Department - Author 2
Biomedical Engineering Department
Degree - Author 2
BS in Biomedical Engineering
College - Author 3
College of Engineering
Department - Author 3
Biomedical Engineering Department
Degree - Author 3
BS in Biomedical Engineering
Date
3-2026
Primary Advisor
Christopher Heylman, College of Engineering, Biomedical Engineering Department
Additional Advisors
Soph Ziemian, College of Engineering, Biomedical Engineering Department
Abstract/Summary
This project focuses on developing an atraumatic cervical stabilization device that serves as a modern alternative to the traditional tenaculum used during IUD insertion procedures. Current devices rely on sharp metal prongs that pierce the cervix and often cause significant pain and bleeding. The goal of this project is to design a device that provides the same stability and control for clinicians while eliminating the need to puncture cervical tissue. The device is intended to be used by gynecologists, nurse practitioners, physician assistants, primary care physicians, or any medical professional performing an IUD insertion. The device is intended to be used on non-pregnant individuals who are 13 years of age or older with no recent pelvic or vaginal infections and normal uterine anatomy. The purpose is to grasp, manipulate, and stabilize the cervical tissue safely and effectively during IUD placement. The key stakeholders include clinicians, who will benefit from improved ergonomics and usability, and patients who will experience less pain and discomfort with the procedure. Also, regulatory bodies and manufacturers play a key role as they ensure safety and market readiness. The report includes details on the development of this device from the user's needs, to concept generation, verification, and testing. The introduction and background provide a clinical context for the necessity of the device and motivation for design. The objectives describe what the problem statement is as well as important customer requirements and corresponding engineering specifications. The project management relays the timeline of device development as well as the prototyping/testing process and any key deliverables. The detailed design elaborates on the final design including engineering sketches and models. The test plan outlines specific test methods that were carried out to verify functionality based on relevant engineering specifications, which are followed by testing results and performance data. The data gathered provide evidence that the device can be used to grasp the cervix beyond an axial force of 6.5 N, that the device does not puncture cervical tissue, the device has a decrease in pressure on the tissue compared to the traditional tenaculum, the device can be sterilized, and the device is compatible with IUD inserters. The conclusion reflects on the outcomes and details next steps for the project.
URL: https://digitalcommons.calpoly.edu/bmedsp/215