Cervical cancer is the Most common cause of death from cancer in women in Developing Countries (190,000 per annum.) Human Pappilomavirus (HPV) is present and identifiable as the causative agent in over 99% of cases of cervical cancer. An effective screening programme consisting of pelvic exams and Pap smears can prevent over 90% of mortality associated with the disease.
The Pelvic Exam is as important as the Pap Smear in diagnosis as it allows visualisation of pre-cancerous cells by staining of the cervical muscosa. In the absence of a successful immunisation programme screening must be carried out at regular intervals in order to detect cancerous changes before the disease can take hold.
Commercially Available disposable specula cost approximately €3.20. They are transparent which aids visualisation of the walls of the vagina. The hinge mechanism impinges upon the field of view when opened wide and bruising and trauma has been reported to the vaginal mucosa due to the closure of the hinged blades on a skin fold.
In addition to this, reusable metal specula can cost over €60. They can also become contaminated with HPV which can be destroyed with autoclaving but by chemical sterilisation, dessication or low-temperature sterilisation. This can contribute further to the spread of HPV and thus cervical cancer risk.
Ours is designed as a single-use plastic speculum. The device can be made in a wide range of different sizes to accommodate different patients. A future development could be the use of a transparent material in printing the device.
We designed the speculum with a low-profile design which aids insertion. The handle is ergonomically designed and guides the thumb to a grip for separating the blades. There is no hinge which eliminates the risk of mucosal trauma and prevents the field of view becoming narrower.
3D printing was done on an Ultimaker 2 3D printer with polylactic acid (PLA) as the material. The 3D CAD model was designed in Solidworks® and imported to Cura. The speculum was printed under normal print speed and normal PLA settings: 20% fill density, 50 mm/s print speed, 0.1 mm layer height, and 210°C temperature. One speculum on normal print speed took 9 hours and 15 minutes. 8 metres of filament were used and one speculum had a material cost of €2.80.
The speculum was tested on a model used for training medical students and was successful.