(038) Development of a Vaginal Dilator and Home Insemination Device for Cis-And Transgender People, Based on Actual Pelvic Anatomy

Abstract

Abstract Introduction Genital gender-affirming surgery (gGAS) is a rapidly evolving surgical field. Specific to feminizing gGAS, one surgical option pertains to vaginoplasty with creation of a neovaginal canal. Given this canal is commonly lined with skin, peritoneum, or colon, women who undergo these procedures as part of their gender affirmation must commit to life-long self-dilation and douching to maintain canal patency and hygiene. Current 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 also 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 which cater to this specific population. Objective 1) To design a vaginal dilator which more accurately reflects pelvic and vaginal canal anatomy, 2) Design a novel dilator which combines dilation, douching, and depth measurement functions, and 3) Modify our new dilator-douche device for use with semen for home insemination by both cis- and transgender women, and, transgender men seeking to become pregnant. Methods A radio-opaque catheter was placed into the neovaginal canal of 12 transgender women who underwent vaginoplasty with canal creation. C-Arm fluoroscopy delineated canal curvature based on the catheter. In addition, gynecologic texts and instruments were examined to ascertain the shape of a cisgender woman’s vaginal canal. Based on these findings, a novel dilator was designed and 3-D printed. Results A smooth “S-shape” was found in the vaginal canal of both cis- and transgender women, consistent with the shape of cervical dilators. In cisgender women, the vaginal vault, which is elastic, is closer to the introitus than that of transgender women. The cervix is typically anteriorly located between 0.5 to 4cm proximal to the posterior fornix. Our vaginal dilators (Figure 1a) (five, each 8–12cm circumference) and insemination device (Figure 1b-c) (9cm circumference) reflect the same smooth S-shaped design. Our dilators have depth markings, side-wall grooves to allow air and liquid to pass, and, can be fitted with a douche-bulb to maintain hygiene. Our insemination device can accommodate a 10cc syringe and has a recessed anterior wall 0.5–4cm from the tip to deposit semen around the cervix for conception. Conclusions The design improvements shown with respect to this dilator-douche device should make dilation and douching more comfortable, 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.