Retractable Cuff Balloon for Bioabsorbable Stent Delivery
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Solution Overview
Problem
Bioabsorbable vascular stents/scaffolds (BVS) pose challenges in safe and reliable delivery, deployment, and expansion due to their bulkiness, fragility, and non-radiopaque materials, which can lead to malapposition and adverse events like blood clots, as existing technologies struggle to precisely and uniformly expand these devices without causing undue stress.
Innovation Solution
A balloon system with retractable cuffs and tapered cones, designed for precise stent deployment and re-expansion, allowing for safe and reliable delivery and post-placement adjustments without the need for balloon exchange, utilizing a balloon-cuff combination that retracts into receiving trenches for re-use.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If conventional balloons are used to expand BVS, then the balloon can be simple in design, but it cannot provide precise and uniform expansion without causing undue stress on the stent material
Solution Approach 1:
The balloon is divided into multiple functional zones: a central expansion zone for uniform stent expansion, proximal and distal retention zones with cuffs for securing the stent, and tapered cones for controlled inflation. This segmentation allows each zone to perform its specific function optimally while maintaining overall precision.
Solution Approach 2:
Different portions of the balloon have different properties: the central portion is designed for uniform expansion, the cuffs are positioned at specific locations for retention, and the cones are tapered at specific angles for controlled inflation. This local differentiation enables precise and uniform expansion without undue stress on the stent material.
2Strength
If BVS are made stronger to handle bulkiness, then they become more fragile due to material composition and processing
Solution Approach 1:
The balloon system provides dynamic control during delivery and deployment through controlled inflation and deflation cycles. The retractable cuffs can be positioned and released dynamically, allowing the system to adapt to different vessel conditions and stent states, thereby improving reliability despite the fragility of BVS.
Solution Approach 2:
The retention cuffs are positioned beforehand to provide cushioning and protection during the delivery and deployment process. This prevents direct stress on the fragile BVS material while maintaining the necessary strength for handling the bulkier structure.
3Adaptability or versatility
If BVS are made from non-radiopaque materials to enable bioabsorbability, then they cannot be visualized using conventional X-ray technologies
Solution Approach 1:
The balloon system serves as an intermediary that provides visible markers and controlled expansion. The balloon itself can be made with radiopaque markers that are visible under X-ray, allowing the operator to track the position and expansion of the non-radiopaque BVS during the procedure, thus compensating for the lack of stent visibility.
4Device complexity
If a single balloon is used for both delivery and post-placement expansion, then device complexity is reduced, but the balloon must be retractable to allow re-use
Solution Approach 1:
The cuffs are designed to be dynamically retractable, allowing them to be positioned during delivery and then retracted to enable post-placement expansion with the same balloon. This dynamic capability reduces the need for multiple balloons while maintaining ease of operation through controlled retraction and positioning.
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 balloon system ensures precise and uniform expansion of BVS, reducing the risk of post-implantation dislodgment and geographic misses, facilitating re-expansion and adjustments, particularly beneficial for bioabsorbable stents not visible under conventional x-ray, by using retractable cuffs that retract into the balloon, allowing for a greater working length and controlled expansion.
Implementation Method 1
inflating the balloon with inflation fluid to expand the elongated central portion of the balloon
Implementation Method 2
upon inflation of the balloon, the first retractable cuff retracting from the first tapered cone such that the first retractable cuff is disposed substantially within the first receiving trench
Data Source
AI summary
A balloon system for delivery of a device. The balloon system includes a balloon including: an elongated central portion including a proximal tapered cone and a distal tapered cone, the elongated central portion and the proximal and distal tapered cones being in an uninflated state; a proximal receiving trench adjacent the proximal tapered cone and a distal receiving trench adjacent the distal tapered cone, and a distal backstop adjacent the distal receiving trench, the distal receiving trench being defined by the distal backstop and the distal tapered cone; and a proximal retractable cuff disposed over the proximal receiving trench and the proximal tapered cone and a distal retractable cuff disposed over the distal receiving trench and the distal tapered cone.