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Background <p>Vaginal dilator therapy is essential for the management of vaginal stenosis following pelvic radiotherapy and for treating genito-pelvic pain/penetration disorders. Existing dilators offer no objective feedback, limiting documentation and reducing adherence.</p> Objective <p>To design and develop a thermochromic, silicone-coated vaginal dilator that provides measurable and visual biofeedback during therapy.</p> Methods <p>A structured medical device development framework was employed. Thermosensitive stereolithography-printed cores with pigments transitioning at 28&#xa0;°C were encapsulated in medical-grade silicone, and permanent engraved depth and diameter scales were added. Dimensional accuracy, surface finish, mechanical integrity, and chromatic responsiveness were evaluated. Device application and features help understand the application in real word.</p> Results <p>The prototype demonstrated high precision (± 0.05&#xa0;mm), surface uniformity (Ra &lt; 0.8&#xa0;μm), consistent colour-change performance, and strong mechanical stability. Integrated scales facilitated quantifiable assessment of insertion depth and diameter. The dual biofeedback mechanism transforms vaginal dilation into a measurable rehabilitation practice.</p> Conclusion <p>This thermochromic vaginal dilator represents a significant innovation in gynecologic rehabilitation, offering objective feedback, improved user confidence, and the potential to enhance adherence. The device is ready for clinical validation.</p>

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Design and Development of a Silicone Vaginal Dilator with Thermochromic Properties for Quantifiable Biofeedback in Gynecologic Rehabilitation

  • 期刊论文

  • 发表日期：

    2026年6月14日

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  • Aditi Agrawal,
  • Ashwini Bulbuli,
  • Ritikesh Pattnaik

摘要

Background

Vaginal dilator therapy is essential for the management of vaginal stenosis following pelvic radiotherapy and for treating genito-pelvic pain/penetration disorders. Existing dilators offer no objective feedback, limiting documentation and reducing adherence.

Objective

To design and develop a thermochromic, silicone-coated vaginal dilator that provides measurable and visual biofeedback during therapy.

Methods

A structured medical device development framework was employed. Thermosensitive stereolithography-printed cores with pigments transitioning at 28 °C were encapsulated in medical-grade silicone, and permanent engraved depth and diameter scales were added. Dimensional accuracy, surface finish, mechanical integrity, and chromatic responsiveness were evaluated. Device application and features help understand the application in real word.

Results

The prototype demonstrated high precision (± 0.05 mm), surface uniformity (Ra < 0.8 μm), consistent colour-change performance, and strong mechanical stability. Integrated scales facilitated quantifiable assessment of insertion depth and diameter. The dual biofeedback mechanism transforms vaginal dilation into a measurable rehabilitation practice.

Conclusion

This thermochromic vaginal dilator represents a significant innovation in gynecologic rehabilitation, offering objective feedback, improved user confidence, and the potential to enhance adherence. The device is ready for clinical validation.