Angioplasty Balloon Scoring Structure for Calcified Plaque Dilation
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Solution Overview
Problem
Conventional balloon catheters struggle to effectively dilate calcified or fibrous plaques due to their resistance to expansion pressures, making it difficult to completely restore patency in stenosed regions.
Innovation Solution
The angioplasty balloon catheter features a scoring structure that exerts a radially inward compressive force, expanding outward when the balloon inflates and contracting inward when it deflates, assisting in both dilation and deflation, and is free from attachment to the balloon, allowing it to maintain contact and facilitate the expansion and contraction of the balloon without being implanted as a stent.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional balloon catheters are used to dilate calcified or fibrous plaques, then the procedure is simple, but the dilation effectiveness is poor due to resistance to expansion pressures
Solution Approach 1:
The balloon surface is segmented with multiple scoring members that protrude outward, creating localized stress concentration points. These segmented scoring members enable the balloon to effectively engage and fracture calcified or fibrous plaques that resist conventional uniform expansion pressures.
Solution Approach 2:
The scoring members are pre-positioned on the balloon surface before inflation. When the balloon is inflated, these pre-positioned scoring members immediately engage the plaque and create fractures, preparing the plaque for subsequent dilation. This preliminary action of scoring the plaque surface enhances overall dilation effectiveness.
2Reliability
If high inflation pressures are used to dilate resistant plaques, then dilation effectiveness improves, but the risk of plaque dislodgment increases
Solution Approach 1:
Instead of applying uniform high pressure across the entire balloon surface, the scoring members concentrate the dilational force at specific localized points where the plaque is most resistant. This local quality approach allows effective plaque fracture while distributing the overall pressure load, reducing the risk of sudden plaque dislodgment.
Solution Approach 2:
The scoring members create micro-fractures and vibrations in the plaque structure during inflation, which helps to weaken and fragment the calcified or fibrous material. This mechanical vibration effect facilitates progressive plaque breakdown without requiring excessive inflation pressures that could dislodge entire plaque segments.
3Reliability
If a scoring structure is attached to the balloon, then plaque engagement improves, but manufacturing complexity increases
Solution Approach 1:
The scoring members are merged with the balloon structure by being integrally formed from the same elastomeric material or by being permanently embedded in the balloon wall during manufacturing. This merging eliminates the need for separate attachment processes, maintaining manufacturing simplicity while ensuring the scoring members remain securely positioned during use.
Solution Approach 2:
The balloon is constructed using composite materials that incorporate the scoring members as an integral part of the balloon wall. This composite structure allows the scoring members to be formed simultaneously with the balloon or embedded during a single manufacturing process, avoiding additional assembly steps and maintaining ease of manufacture.
4Reliability
If the scoring structure remains expanded after balloon deflation, then stent support is provided, but the device complexity and implantation permanence increase
Solution Approach 1:
The scoring members are designed to be dynamic rather than static, allowing them to expand with the balloon during dilation and then contract back toward the balloon surface when the balloon deflates. This dynamic behavior provides temporary plaque engagement during the procedure while avoiding permanent implantation, simplifying the overall device structure compared to self-expanding stents.
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
This design enhances the ability to dilate calcified or fibrous lesions with lower inflation pressures, improves the balloon's manufacturing and operational simplicity, and reduces the risk of plaque dislodgment, while maintaining continuous contact with the balloon to assist in both expansion and deflation processes.
Implementation Method 1
The scoring structure is expanded from an initial relaxed configuration having a reduced diameter smaller than the minimum diameter of the dilation balloon when the dilation balloon is deflated, to an expanded configuration when the dilation balloon is inflated
Data Source
AI summary
A circumferentially and longitudinally continuous scoring structure having a diameter in an initial unrestrained state that is smaller than a deflated diameter of the balloon is disposed around an outer surface of the balloon in an expanded configuration. The scoring structure continually exerts a radially inward compressive force against the balloon such that when the balloon is expanded from a deflated configuration to an inflated configuration, the scoring structure expands in a radially outward direction and remains in continuous compressive contact with at least a portion of the balloon as the balloon unfolds. The scoring structure may be entirely free of attachment to the balloon and catheter, and may extend substantially a length of a working region of the balloon. The scoring structure may include a plurality of circumferentially compressible members connecting longitudinal members.