Motorized Girth Adjustable Dilator with Dilation and Pressure Measurement for Anorectal Disorders, Designed to Improve Patient Adherence to Treatment via Static-Passive Stretching

Abstract Anorectal disorders, such as anismus and anal stenosis, are pressing concerns in colorectal medicine. Anismus accounts for up to 25% of all chronic constipation cases. Anal stenosis, which can result from surgeries (including hemorrhoidectomy, obstetrical injury, or trauma), radiation therapy for anal cancer, or chronic medical conditions such as Crohn's disease, accounts for 1.5 million new cases annually. Combined, these disorders lead to over 15 million new cases in the USA each year. Conventional Anal Dilation (AD) treatment uses fixed-girth push-type dilators. However, patient adherence is a significant concern, with rates dropping to as low as 25%. The main issue is the pain associated with the size jump progression between dilators, which averages a 24% increase in girth. The fear of pain and injury from using fixed-girth dilators, especially among those who have undergone surgery or experienced trauma in the anal region, results in patients' reluctance to continue the treatment. To address these challenges, Lumina Medical introduces an innovative and affordable solution: the Motorized Girth Adjustable Dilators. These innovative devices facilitate Static-Passive Stretching (SPS) within the anal canal, and are complemented by real-time dilation and pressure measurement. This dual functionality supports patients in home-based effective self-dilation and aids clinicians in administering atraumatic treatment by offering customized dilation protocol. The key to our innovation is the integration of a cost-effective shaft girth expansion mechanism coupled with an electronic system, offering a significant competitive advantage over existing products by 1 - Our dilator's shaft enables SPS in the anal canal by expanding in millimeter increments. These increments are imperceptible to the user, thus ensuring gentle dilation while maximizing comfort and efficiency. 2 - Our electronic system, including Force-Sensitive Resistors (FSRs), measures dilator shaft girth and intracanal pressure in real time, crucial for optimizing treatment protocols and contributing to scientific data collection. 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 anal dilation therapy. Building on our globally patented Girth Adjustable Dilator technology, Lumina Medical seeks to revolutionize the anal dilation field. Our goal for Phase I is to determine the technical merit, feasibility, and commercial potential of our project. Phase I – Proof of Concept (Clinical Trial Not Allowed) will comprise: Aim 1. Transitioning to a Medical Device via High-Res 3D Printing Prototype Development, Aim 2. Advanced Prototypes via Injection Molding, and Aim 3. Validate Mechanical Performance and Surrogate Model Efficacy. Our Motorized Girth Adjustable Dilator holds the potential to redefine the treatment landscape for anal dilation, whether arising from chronic conditions or surgical procedures. By introducing this affordable innovative solution to the market, we aspire to benefit a vast patient demographic and establish a new standard in anal care. Phase II will include extensive product non- clinical bench testing aligning with FDA 510(k) clearance, clinical trials, and preparations for commercialization.