Innovative Vaginal Girth Adjustable Dilator with Precise Dilation Monitoring, designed to Significantly Improve Patient Pain Management in Pelvic Floor Disorder Treatment

Abstract Chronic pelvic pain associated with vaginal and pelvic floor disorders is extremely common. Various medical conditions, including post-menopause vaginal atrophy, vaginal stenosis, sequelae of pelvic radiation therapy for cancer treatment, dyspareunia, vulvodynia, vaginismus, and others, are known to be contributing factors to this pain. Over 25 million women in the USA are affected annually by one of these conditions. Despite opioids' limited efficacy in functional restoration, there has been an overreliance on them for treating chronic pelvic pain in recent decades. Untreated conditions may result in vaginal canal narrowing and altered elasticity, affecting fertility, menstrual flow, and sexual function, leading to severe psychological distress. This can perpetuate a cycle of increased opioid use, escalating the risk of addiction, overdose, and long-term morbidity. Vaginal Dilation (VD) is a conventional treatment method used as an alternative or complement to drugs, mainly employing fixed-girth push-type dilators. However, patient adherence to VD is a significant concern, with rates dropping to as low as 25%, primarily due to pain associated with significant size jumps in fixed-girth dilator shafts, averaging a 24% increase in girth. Most patients describe this size jump progression as painful, even traumatic. To address these challenges, Lumina Medical introduces an innovative and affordable solution: the Upgraded Girth Adjustable Dilators. This technology enables patients to undergo atraumatic vaginal self-dilation at home and allows clinicians to administer atraumatic vaginal dilation. This innovation comprises two key points: 1) Our dilators' shaft enables Static-Passive Stretching (SPS) in the vaginal canal by expanding radially in millimeter increments. These increments are imperceptible for the user, ensuring a gentle dilation and maximizing comfort and dilation efficiency. 2) The dilation measurement feature provides precise, real-time monitoring of dilation progress, crucial for assessing treatment efficacy, optimizing treatment protocols, and contributing to scientific research. SPS is the most efficient physical therapy to enhance flexibility and is both patient-friendly and highly effective in terms of pain management. Currently, no device on the market offers an affordable SPS vaginal dilation therapy. Building on our globally patented Girth Adjustable Dilator technology, Lumina Medical seeks to revolutionize the vaginal dilation field. Our goal for Phase I is to determine the technical merit, feasibility, and commercial potential of our project. Phase I will comprise: Aim 1. Transitioning to a Medical Device via High-Res 3D Printing Prototype Development, Aim 2. Developing Advanced Prototypes via Injection Molding and Aim 3. Validate Mechanical Performance and Surrogate Model Efficacy. Our Upgraded Girth Adjustable Dilator holds the potential to redefine the treatment landscape for vaginal dilation, whether arising from chronic conditions or surgical procedures. By introducing this innovative and affordable solution to the market, we aspire to benefit a vast patient demographic and establish a new standard in vaginal care. Phase II will include extensive product non-clinical bench testing aligning with FDA 510(k) clearance, clinical trials, and preparations for commercialization.