Testing & Results
Testing & Results
Embedded Files
Testing Methods
Testing Methods
The dilator was first calibrated to mmHg by connecting the balloon to both the dilator and a pressure gauge.
A Pressure vs. Force test was conducted using a hexagonal chamber simulating LENT-SOMA grade 1 model
The vaginal porcine tissue was inflated to record pressure data and capture expansion through two cameras.
The video data was analyzed and synced to the pressure data using Computer Vision Analysis.
Pressure vs. Force Testing
Pressure vs. Force Testing
Results from the Pressure/Force test show that the pressure inside the balloon could reach 600 mmHg and create a force of up to 50 N inside the hexagonal grade 1 chamber.
This suggests that the small 3V pump can generate more than enough pressure and force for dilation.
Ex Vivo Porcine Tissue Testing
Ex Vivo Porcine Tissue Testing
Volume vs. Pressure
Ex-vivo testing of the dilator using porcine vaginal tissue shows that a dilator pressure of 321 mmHg increased the volume of the vaginal tissue to 135 cm3 and 169 cm3 on the 1st and 20th trial respectively.
The porcine tissue volume reaches 139% of its original size after 20 trials. Therefore, the MiaFit vaginal dilator shows evidence of increased deformation of the vaginal canal after 20 dilation trials.
Changes in Radii & Height
Five cuts (R1-R5) were placed across each of the images to represent five radii along the length of the vaginal canal. It was found that over the 20 trials, the anterior end of the canal experienced a greater change in radii compared to the posterior end (A).
At a maximum pressure of 325 mmHg, the vaginal tissue was able to stretch to 2.2 times its original volume (B). This suggests that there may be some remodeling of the vaginal wall after multiple dilation trials, which is a necessary outcome of vaginal dilatory therapy for the treatment of vaginal stenosis.
By: German Gonzalez
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