Midurethral Sling Stabilizer for Tension-Free Placement
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Solution Overview
Problem
Midurethral slings used to treat stress urinary incontinence often shift or become tense after the removal of their protective sheath, leading to failure or voiding dysfunction due to lack of optimal stabilization during placement.
Innovation Solution
A midurethral sling stabilizer with a partial aperture at its distal end is used to maintain the sling in a tension-free position beneath the urethra, preventing slippage or rolling, and allowing for the removal of the sheath without inducing tension, constructed from materials like stainless steel, silicone, or plastic for biocompatibility and surgical compatibility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the protective sheath is removed from the sling, then the sling can be adjusted and positioned, but the sling may move cephalad or become tense leading to placement failure
Solution Approach 1:
The stabilizer is inserted and positioned before the sheath is removed, establishing a stable framework that prevents sling movement during the critical transition period when the protective sheath is taken off. This preliminary stabilization ensures the sling remains in the correct position throughout the adjustment process.
Solution Approach 2:
The stabilizer acts as an intermediary device between the sling and the surrounding tissue, providing mechanical support and preventing direct interaction that could cause unwanted movement or tension. The stabilizer's structure with partial apertures allows it to encompass and secure the sling while maintaining proper positioning.
2Reliability
If the sling is placed without tension for optimal function, then voiding symptoms improve, but the sling becomes unstable and may roll or fold after sheath removal
Solution Approach 1:
The stabilizer provides counterbalancing support to the tension-free sling, compensating for the lack of inherent stability. By encompassing the sling through its partial apertures, the stabilizer creates a counteracting force that prevents rolling or folding while allowing the sling to maintain its optimal tension-free state for functional performance.
Solution Approach 2:
The stabilizer is constructed from flexible biocompatible materials that can conform to the anatomical structures while maintaining structural integrity. This flexibility allows the stabilizer to adapt to the sling's position and provide stable support without creating tension, preventing structural instability while preserving the tension-free functional state.
3Reliability
If a stabilizer structure is added to prevent sling movement, then placement stability improves, but device complexity increases
Solution Approach 1:
The stabilizer is divided into multiple segments or components including a proximal end, distal end, and intermediate portions with partial apertures. This segmentation allows each section to perform specific functions - the partial apertures encompass the sling while the overall structure remains relatively simple and manageable, reducing device complexity while maintaining placement stability.
Data Source
AI summary
A sling for stress urinary incontinence (SUI) may be placed and stabilized using a midurethral sling stabilizer. First, a sling may be placed beneath the urethra in a position to support the urethra, without tension. The midurethral sling stabilizer may then be inserted in a manner where the distal end partially encompasses and stabilizes the sling through a partial aperture and stabilizes the sling in a desired position, without tension. Once the sling is stabilized in the desired position, the sheath may be removed from the sling.