Intravaginal Insert Urethral Support Tether Removal
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Solution Overview
Problem
Current management options for stress urinary incontinence (SUI) in women are often embarrassing, uncomfortable, and costly, with existing devices like absorbent pads, urethral plugs, and surgical approaches carrying risks and requiring frequent medical visits, while behavioral therapies can be time-consuming and ineffective for many.
Innovation Solution
A firm, tapered intravaginal insert made of medical-grade materials like ABS and textured EVA, with a tether for easy removal, provides anterior urethral support to prevent leakage during increased intraabdominal pressure, eliminating the need for applicators and reducing odor concerns.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If absorbent pads and diapers are used for SUI management, then leakage protection is provided, but embarrassment and odor are increased
Solution Approach 1:
The invention extracts the supportive function from external pads and relocates it to an intravaginal device that provides structural support directly at the urethra, eliminating the need for absorbent external materials and their associated odor and embarrassment issues
2Reliability
If urethral plugs are used to occlude the urethra, then leakage is prevented, but comfort is reduced and infection risk is increased
Solution Approach 1:
The invention introduces the vaginal wall as an intermediary structure to provide support indirectly. Instead of placing a plug directly in the urethra (which causes discomfort and infection risk), the device engages the vaginal wall to create a cradle that supports the urethra from below, achieving leakage prevention without direct urethral occlusion
Solution Approach 2:
The device is segmented into multiple functional components: proximal engagement features that secure to the vaginal wall, a body that creates the support cradle, and a distal portion that positions the support. This segmentation allows the device to achieve urethral support without requiring direct urethral insertion
3Reliability
If intravaginal pessaries are used, then urethral support is provided, but device complexity and medical visit requirements are increased
Solution Approach 1:
The invention enables self-service insertion and removal by designing the device with a tapered profile that allows easy insertion by the user without medical assistance. The device includes self-retaining features that secure it in place without requiring professional fitting, and a tether system that enables easy removal by the user at home
Solution Approach 2:
The device incorporates pre-designed engagement features and structural elements that automatically position and secure the device upon insertion, eliminating the need for professional fitting adjustments. The tapered profile and engagement features are pre-configured to work together to secure the device in the correct position
4Reliability
If behavioral therapy is used for SUI, then pelvic floor muscles are strengthened, but time and dedication requirements are increased
Solution Approach 1:
The invention replaces the mechanical training process (repeated pelvic floor exercises over time) with a mechanical support system (the intravaginal device) that provides immediate urethral support. Instead of requiring the user to dedicate time to strengthening exercises, the device provides the support function mechanically and passively
Data Source
AI summary
An intravaginal insert device for the management of stress urinary incontinence is disclosed. The insert device can provide an insert body shaped for comfortable and secure placement in the vagina at a depth for support of the urethra. The insert body can be formed by a mold overlay on a plastic core that is provides with interstitial gaps to enhance the integration of the overlay with the core. The core can further provide a hitch for attachment of a tether, such as string, to facilitate removal of the insert after use.