Vaginal System for 13-Cycle Birth Control
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Solution Overview
Problem
Current contraceptive methods, such as oral pills and subcutaneous implants, face compliance issues due to daily reminders and frequent refills, while intravaginal rings require regular replacements and prescription refills, necessitating a more convenient and long-term solution for birth control.
Innovation Solution
A vaginal system configured for thirteen 28-day cycles using segesterone acetate and ethinyl estradiol, compatible with natural rubber latex, polyisoprene, or polyurethane condoms, which releases hormones for 21 days and includes a secondary non-estrogen contraception method when removed for more than two cumulative hours, ensuring continuous protection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If oral contraception is used, then birth control effectiveness is achieved, but compliance is reduced due to daily pill reminders and frequent refill needs
Solution Approach 1:
The patent divides the contraceptive system into a primary vaginal system for long-term hormone delivery and a secondary backup method for situations where the primary system is removed or expelled. This segmentation allows the main system to provide automatic long-term protection while the backup handles edge cases, eliminating the need for daily pills while maintaining compliance through simple insertion/removal cycles.
Solution Approach 2:
The vaginal system is designed to be self-contained with a long duration of action (up to 13 cycles), eliminating the need for daily user intervention to take pills or obtain frequent refills. The system automatically provides contraception for extended periods, with users only needing to insert or replace the system periodically, significantly improving ease of operation while maintaining reliability.
2Ease of operation
If subcutaneous implants or IUDs are used, then compliance is improved by reducing daily reminders, but insertion and removal require medical professionals
Solution Approach 1:
The vaginal system is designed for self-insertion and self-removal by the user without requiring medical professionals. The simple ring-like structure can be easily placed in the vagina by the user, and removal is equally straightforward, eliminating the need for clinical visits while maintaining long-term compliance benefits.
Solution Approach 2:
The patent creates a homogeneous user experience across different contraceptive methods by making the vaginal system as easy to manage as daily pills (requiring minimal user action) while providing the long-term protection of implants or IUDs. The system maintains consistent effectiveness across multiple cycles without requiring medical intervention for routine maintenance.
3Ease of operation
If intravaginal rings are used, then daily pill compliance is improved, but regular prescription refills and replacements are still needed
Solution Approach 1:
The vaginal system is pre-loaded with hormones for extended periods (up to 13 cycles), allowing users to insert the system and receive continuous protection without needing to obtain new supplies frequently. The long duration of action eliminates the need for regular prescription refills and frequent replacements, saving users time while maintaining compliance.
Solution Approach 2:
The system provides continuous contraceptive protection for up to 13 cycles without interruption, eliminating the need for frequent refills and replacements. The hormone delivery continues automatically throughout the entire duration, ensuring uninterrupted protection and reducing the time users spend managing their contraception supply chain.
4Ease of operation
If the vaginal system is removed or expelled for more than two cumulative hours, then user convenience is improved, but contraceptive efficacy is compromised
Solution Approach 1:
The patent provides beforehand cushioning by requiring users to employ a secondary non-estrogen contraception method when the vaginal system is removed or expelled for more than two cumulative hours. This backup mechanism compensates for the potential loss of efficacy during removal periods, ensuring continuous protection without requiring users to constantly monitor or restrict their convenience.
Solution Approach 2:
The secondary contraception method acts as an intermediary backup that activates when the primary vaginal system is not in place. This intermediary ensures that contraceptive protection is maintained even when the primary system is removed for convenience, bridging the gap between user comfort and contraceptive reliability.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The vaginal system provides effective birth control for up to 13 cycles with minimal user intervention, maintaining contraceptive efficacy even when exposed to various condom materials and reducing the need for frequent refills or replacements.
Implementation Method 1
a vaginal system configured to release an average of approximately 0.15 mg/day of segesterone acetate and an average of approximately 0.013 mg/day of ethinyl estradiol
Data Source
AI summary
The present disclosure describes a vaginal system comprising segesterone acetate and ethinyl estradiol configured for thirteen 28-day product-use cycles that is compatible with male condoms comprising natural rubber latex, polyisoprene, or polyurethane and a method of providing birth control using the vaginal system wherein a secondary contraception is employed when the vaginal system is removed or expelled from the vagina for specified amounts of time during any of the product-use cycles.