Expandable Intravaginal Pessary Ring for Pelvic Organ Prolapse
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Solution Overview
Problem
Current non-surgical treatments for pelvic organ prolapse, such as pessaries, lack effective mechanisms for providing sustained intravaginal support and drug delivery, and do not adequately address symptoms like prolapse, incontinence, and postoperative care.
Innovation Solution
An intravaginal support apparatus with a pessary ring that transitions between annular and narrowed configurations, featuring expandable elements like balloons for pressure application and an irrigation unit for drug delivery, providing sustained support and treatment by expanding within the vaginal lumen.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional pessaries are used for non-surgical treatment of pelvic organ prolapse, then surgical procedures are avoided, but effective sustained intravaginal support and drug delivery mechanisms are lacking
Solution Approach 1:
The pessary ring is designed to be expandable from a compressed insertion state to an expanded support state. The ring includes radial expansion elements that can be actuated to increase the diameter of the ring, providing adjustable support force. This dynamic transformation allows the device to adapt to different patient needs and anatomical variations while maintaining reliable support.
Solution Approach 2:
The intravaginal device integrates multiple functions into a single apparatus: mechanical support through the expandable ring, drug delivery through reservoirs with controlled release mechanisms, and irrigation capabilities. This multi-functionality addresses the limitation of traditional pessaries by providing both structural support and therapeutic drug delivery, eliminating the need for separate devices.
2Reliability
If the pessary ring is expanded to provide support, then prolapse symptoms are alleviated, but the device cannot be easily inserted
Solution Approach 1:
The pessary ring employs a dynamic expansion mechanism that allows it to be inserted in a compressed, low-profile state and then expanded to its functional diameter once positioned. The radial expansion elements can be actuated by the user or automatically, transforming the ring from a compact insertion configuration to an expanded support configuration, thereby resolving the contradiction between ease of insertion and support effectiveness.
Solution Approach 2:
The expandable ring structure allows the support elements to be nested within a smaller diameter configuration during insertion, similar to nested dolls. Once inserted into the vagina, the ring is expanded to its full diameter to provide the necessary support. This nesting principle enables the device to pass through the vaginal opening in a compressed state while maintaining the capability to expand to a larger size for effective prolapse support.
3Reliability
If expandable elements are added to the pessary ring, then additional support and pressure control are achieved, but device complexity increases
Solution Approach 1:
The expandable elements of the pessary ring are inflated using a balloon mechanism that can be filled with fluid or gas. This pneumatic/hydraulic expansion provides controlled and adjustable pressure distribution around the pelvic organs. The balloon-based expansion mechanism is simpler than mechanical actuation systems while providing reliable pressure control, thus improving support effectiveness without excessively increasing device complexity.
Solution Approach 2:
The expandable elements utilize flexible balloon structures that can be inflated to provide uniform pressure distribution. These thin-film balloons are simpler in construction compared to rigid mechanical expansion mechanisms and can be easily controlled through fluid injection. The flexible nature of the balloons allows them to conform to the vaginal anatomy while providing the necessary support pressure, resolving the contradiction between pressure control reliability and mechanism simplicity.
4Duration of action of stationary object
If the device remains in the vagina for extended periods, then sustained support is provided, but infection risk increases
Solution Approach 1:
The intravaginal device integrates an irrigation system that can be activated to flush the vaginal environment around the device. This irrigation capability, combined with the drug delivery function, creates a multi-functional system that not only provides mechanical support but also actively manages infection risk through regular cleaning and antimicrobial drug release, thereby enabling extended wear duration safely.
Solution Approach 2:
The device incorporates controlled-release drug reservoirs that continuously release antimicrobial agents over the wear period. This continuous action of drug delivery, combined with periodic irrigation, maintains a protective environment around the device throughout its extended residence in the vagina, preventing infection while providing sustained mechanical support.
Data Source
AI summary
An intravaginal support apparatus. The intravaginal support apparatus comprises a pessary ring having a substantially annular configuration and a narrowed configuration, a locking mechanism which retains and switches between the annular configuration and the narrowed configuration, and one or more expandable elements having expanded and unexpanded configurations, attached to one or more of the locking mechanism and the pessary ring. The pessary ring laterally expands from the narrowed configuration to the annular configuration; the expandable element expands outwardly of the pessary ring, from the unexpanded configuration to the expanded configuration.