3-D Printed Vaginal Molds for the Treatment of Vaginal Stenosis Following Pelvic Radiation

Disclaimer:

• The information provided on this site is for educational and research purposes only and does not substitute for professional medical advice.
• You must consult a medical professional or healthcare provider if you are seeking medical advice, diagnoses, or treatment.
• We are not liable for risks or issues associated with using or acting upon the information provided.

This is a vaginal mold designed for women with a history of vaginal stenosis following pelvic radiation or inflammatory conditions of the vagina and is designed to help with vaginal dilation.

The link to the corresponding study will be submitted later for publication!

Advantages of this Design:
 

• Good ergonomics.
• Adaptable to different sizes and hardness levels.
• Only one piece design (No supports!)
• Can be disinfected. 
• No pressure points that hurt over time (no sharp edges!). 
• Easy to insert and remove by the patient.
• Including subtle storage boxes.

In the United States, obtaining approval from the U.S. Food and Drug Administration (FDA) is necessary to commercialize the use of manufactured devices, including those created through 3D printing, for the general public. These devices must undergo rigorous testing to ensure they are efficient, safe, and fit for their intended purpose before they can be approved. Additionally, premarket notification is required to demonstrate that the new device is "substantially identical" to an existing device, which is crucial for FDA clearance.

This legal requirement also applies in a similar way to many other countries. Therefore, the publication of this print file serves the sole purpose of providing other researchers in this field with the basis for further developments or their own studies.

Printing settings:

Material: TPU or other flexible & chemical resistant materials. 
→ Desinfection of the mold should be possible!!

Slicing: 

0,4 mm Nozzle, 0,15 mm layer height, 15-20% Infill, 2-3 Perimeter, brim optional.

→ The smaller the layer height the better to ensure a smooth surface.
→ The less infill the lighter the mold! 
→ 2-3 Perimeter: Depends a little on the used material. The more perimeter you use, the stiffer and more inflexible the shape becomes. The walls should be waterproof!

Tipp: You can also use bigger nozzle sizes or increase the extrusion width a little.

Scaling:

A particular strength of 3D printing is the easy adaptation of the shape to specific dimensions/requirements. This means you can easily scale this shape in the slicer and adapt it to different sizes/shapes of patients. The only limitation here is the loop, which could no longer be stable enough if printed too small.