(015) DEVELOPMENT OF A VAGINAL DILATOR DEVICE AND A HOME INSEMINATION DEVICE FOR CIS- AND TRANSGENDER PEOPLE, BASED ON THE ACTUAL ANATOMY OF THE PELVIS
Authors: Sandhu S , Mallavarapu S , Garcia M 
Published: June 2024

Abstract

Introduction
Individuals undergoing vaginoplasty with canal creation must undertake life-long self-dilation and douching to maintain canal patency and hygiene. Commercially available dilators and douches are designed for cisgender anatomy, and are either straight, or, have an abrupt upward curve at the tip, inconsistent with neovaginal canal anatomy, which lacks the elasticity of a cisgender woman’s vagina, making it sensitive to dilator shape, and douche nozzle length. In addition, many LGBTQ+ individuals with a uterus seek pregnancy without a male sexual partner, but few devices exist for this population.

Objective
We assessed the vaginal canal shape in transgender and cisgender women and sought to: 1) Design a vaginal dilator which reflects pelvic and canal anatomy. 2) Create a novel dilator that combines dilation, douching, and depth measurement functions. 3) To create a vaginal dilator that can be irrigated with semen by trans men and by cis women seeking pregnancy without a male sexual partner

Methods
A floppy radio-opaque catheter was placed into the neovaginal canal from the introitus to the vault apex of 12 transgender women who underwent vaginoplasty with neovaginal canal creation. C-Arm fluoroscopy delineated canal curvature based on the catheter. In addition, gynaecologic texts were reviewed and both current and historical surgical instruments were examined to ascertain the shape of a cisgender woman’s vaginal canal. Based on these findings, a novel dilator was designed using ink-drawings, whereupon a CAD-file was designed and 3-D printed. A sex-toy company made our initial prototypes.

Results
A smooth “S-shape” was found in the vaginal canal of both cis- and transgender women, consistent with the shape of modern and historical cervical dilators. In cisgender women, the vaginal vault, which is elastic, is located much closer to the introitus than that of transgender women, whose canal is inelastic and fixed. The cervix is typically located on the anterior surface of the canal, and, located between 0.5 to 4cm proximal to the posterior fornix. Our vaginal dilators (Figure 1a) (five, each 8-12 cm circumference) and reflect the smooth S-shaped curvature observed, with depth markings, and, side-wall grooves to allow air and liquid to pass with insertion and withdrawal. The dilator is also hollow with holes at the distal end and can be fitted with a douche-bulb. Our insemination device (Figure 1b-c) is only 9 cm. circumference, is similar in shape but is shorter, is hollow to accommodates a 10cc syringe (for introduction of semen), and has a recessed anterior wall, 0.5-4cm from the tip (where the cervix normally resides) for up to 6cc of semen to pool and bathe the cervix with sperm for conception.

Conclusions
The design improvements shown should make dilation and douching more comfortable, and should improve hygiene and decrease the incidence of granulation tissue. Our inseminator offers a private, at-home means of achieving fertilization for both cisgender and transgender individuals. (U.S. Patent 11638808; Neovaginal and vaginal health devices)

Disclosure
No.