Inflatable Pessary Support for Asymmetric Pelvic Floor Ligaments
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Solution Overview
Problem
Existing vaginal pessaries do not provide targeted mechanical support to loose pelvic floor ligaments, leading to conditions like prolapse and chronic pelvic pain, and lack customization for different ligamentary areas, with temporary use and easy placement being desirable.
Innovation Solution
An inflatable pessary system with independently inflatable balloon portions positioned at the insertion end, allowing differential expansion to provide targeted support to pelvic floor ligaments, including uterosacral ligaments, and can be easily inserted and removed, with optional integration of sensors and electrodes for EMG recording and muscle stimulation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional pessaries are used to support pelvic organs, then organ descent is blocked, but targeted support to loose ligaments is not provided
Solution Approach 1:
The pessary is divided into multiple independently inflatable balloon portions positioned at different locations along the insertion end. Each balloon can be inflated to provide support to specific ligamentary areas (anterior, middle, or posterior compartments) independently, allowing targeted treatment of loose ligaments while maintaining overall organ support.
Solution Approach 2:
Different regions of the pessary are designed with different functional properties through selective inflation of balloon portions. The anterior balloons can provide support to the bladder and urethra, middle balloons to the cervix and uterus, and posterior balloons to the rectum, allowing localized adaptation to specific ligamentary needs without affecting other areas.
2Reliability
If long term pessary placement is used, then continuous organ support is provided, but ulceration occurs especially in older women
Solution Approach 1:
The pessary incorporates balloons that can be periodically deflated and re-inflated, allowing the vaginal tissue to receive periodic relief from continuous pressure. This periodic decompression reduces the risk of ulceration and tissue damage while maintaining overall support, enabling longer-term use without the harmful effects of continuous compression.
Solution Approach 2:
The pessary transitions from a static support structure to a dynamic system where balloon inflation and deflation can be adjusted based on patient needs and tissue response. This dynamic capability allows the support level to be modulated, providing continuous support when needed while allowing tissue recovery periods to prevent ulceration.
3Reliability
If surgical treatment with midurethral sling is used, then ligamentary support is provided, but surgical risks and costs are incurred
Solution Approach 1:
The invention replaces the surgical mechanical sling system with a non-surgical inflatable balloon system. The balloons, when inflated, provide mechanical support to ligaments and pelvic organs through pressure and positioning, achieving similar therapeutic effects without requiring surgical implantation of filaments or sutures into fascial tissue.
Solution Approach 2:
The inflatable balloons serve as an intermediary mechanism between the external application and the internal ligamentary structures. Instead of directly suturing to ligaments as in surgical procedures, the balloons transmit support forces through the vaginal wall to the ligaments, providing indirect but effective ligamentary support without surgical intervention.
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 pessary system effectively supports loose pelvic floor ligaments, reducing prolapse and pelvic pain symptoms, customizable for various ligamentary areas, and allows for intermittent use to prevent ulceration and discomfort, while facilitating self-insertion and removal.
Implementation Method 1
Each balloon can be inflated with air or liquid, such as by use of a syringe attached to a fluid conduit leading to the balloon
Implementation Method 2
When inflated, the balloon expands within a 360 degree area surrounding the pessary device to form a ball or cylinder shape around the pessary axis. The inflated balloon applies pressure to the surrounding areas in the vaginal cavity to support the prolapsed organ.
Data Source
AI summary
A pessary system for providing pelvic floor support for USL and other ligaments. The pessary has an elongated probe with independently inflatable balloons each located substantially the same distance from the insertion end of the probe and which inflate into separate radial sectors. The probe can be inserted into a vaginal cavity and the balloons inflated provide mechanical support to the USLs. Independent inflation of each balloon allows the mechanical USL support provided to be varied on left and right sides to compensate for differences in the degree of degradation and positioning of the USL ligaments on either side.