Non-expandable Pessary with Applicator for Low Expulsion Force
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Solution Overview
Problem
Existing pessary devices for urinary incontinence are often uncomfortable and difficult to insert due to their large size and requirement for digital insertion, which can be challenging for users with limited dexterity or hand strength, and they may expand within the applicator, increasing the expulsion force needed for insertion.
Innovation Solution
A non-expandable intravaginal pessary device with a smaller maximum outer diameter and a convex portion to provide pressure on the urethra, housed within an applicator with a barrel region that minimizes the expulsion force required for insertion, ensuring the device can be easily inserted with reduced frictional force and minimal user effort.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If pessary devices are made large in diameter to provide effective compressive action, then the therapeutic effect is improved, but the insertion difficulty and user discomfort increase
Solution Approach 1:
The pessary device is segmented into multiple functional zones along its longitudinal axis, including a cervix engagement portion, a urethral compression portion, and a vaginal wall support portion. This segmentation allows each zone to perform its specific function independently, enabling the device to provide effective therapy without requiring a uniformly large diameter throughout, thus reducing insertion difficulty while maintaining therapeutic efficacy.
Solution Approach 2:
The applicator system employs a nested structure where the pessary device is inserted within the applicator body, and the plunger is inserted within the applicator barrel. This nested design allows the large-diameter pessary to be delivered through a smaller applicator opening, resolving the contradiction between device size for therapeutic effect and insertion ease.
2Reliability
If pessary devices are made expandable to provide compressive action, then the therapeutic support is improved, but the expulsion force required for insertion increases
Solution Approach 1:
The pessary device is pre-formed and pre-shaped during manufacturing to achieve its final functional configuration before insertion. This eliminates the need for the device to expand after insertion, thereby reducing the expulsion force required while maintaining the necessary support effect through its pre-configured structure.
Solution Approach 2:
The design transitions from expandable materials to a non-expandable, pre-formed structure. By changing the physical state parameter from expandable to fixed, the device maintains therapeutic support through its predetermined geometry rather than through post-insertion expansion, thereby reducing the force required for insertion and expulsion.
3Adaptability or versatility
If digital insertion method is used to insert pessary devices, then the insertion flexibility is improved, but the user accessibility and comfort deteriorate
Solution Approach 1:
The applicator serves as an intermediary device between the user and the pessary. It provides a mechanical interface that allows the pessary to be inserted without direct digital manipulation, making the procedure accessible to users with limited dexterity while maintaining insertion flexibility through the applicator's design features such as the plunger mechanism and ergonomic grip.
Data Source
AI summary
An intravaginal pessary device in an applicator is provided. The device has a top and a bottom, and a sidewall that extends between the top and the bottom. The sidewall, top and bottom form an outer periphery defining a total area of the device. The pessary device has a maximum diameter that is less than about 25 mm. The pessary device and applicator exhibit a maximum expulsion force that is below 1500 grams.


