Finned Angioplasty Balloon Scoring Design
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Solution Overview
Problem
Current angioplasty balloons with cutting or scoring blades face issues such as unintentional incision, perforation, stiffness, difficulty in navigating curved vessels, blade detachment, increased profile leading to longer recovery times, and manufacturing complexity, which limit their effectiveness in treating hardened or calcified lesions.
Innovation Solution
A finned angioplasty balloon with a polymeric tube structure featuring three radially extending fins, selectively positioned along the balloon body, which are integrally formed and equidistantly spaced, allowing for scoring and dilation while maintaining flexibility and reducing the risk of trauma to the vessel.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If cutting blades or wires are mounted on the balloon's external surface, then the ability to score and dilate hardened lesions is improved, but the device stiffness increases making it difficult to navigate curved vessels
Solution Approach 1:
The balloon is divided into distinct functional zones: a scoring section with cutting blades/wires for treating hardened lesions, and curved sections without blades for navigating tortuous vessels. This segmentation allows each zone to perform its specific function optimally without compromising the other.
Solution Approach 2:
Different portions of the balloon have different properties: the scoring section has cutting elements for mechanical disruption of calcified plaque, while the proximal and distal curved sections are blade-free to maintain flexibility and conformability to vessel curvature, reducing the risk of dissection in healthy tissue.
2Strength
If cutting blades or wires are attached to the balloon surface, then lesion scoring effectiveness is improved, but the risk of unintentional incision and perforation increases
Solution Approach 1:
The cutting blades or wires are confined to a specific scoring section of the balloon, leaving proximal and distal regions blade-free. This ensures that cutting action is localized to the lesion site only, preventing unintentional incision or perforation of healthy vessel walls during insertion or withdrawal.
Solution Approach 2:
The balloon is designed to be fully inflated before the scoring section contacts the vessel wall. This preliminary inflation stabilizes the balloon position and ensures that cutting elements engage the lesion intentionally rather than accidentally during device manipulation.
3Strength
If fins extend along the entire length of the balloon, then scoring capability is improved, but melon seeding (slippage from target site) is promoted
Solution Approach 1:
Fins are positioned only on the scoring section of the balloon where cutting action is required, rather than extending along the entire length. This localized fin placement maintains scoring effectiveness while reducing the surface area that could interact with the vessel wall to cause slippage or melon seeding.
4Strength
If metal blades or wire frames are used for scoring, then lesion cutting ability is improved, but the overall device profile increases requiring larger insertion sheaths
Solution Approach 1:
The cutting elements are integrated into a thin-walled polymeric balloon structure rather than using bulky metal frames. This allows the scoring section to maintain structural integrity and cutting capability while keeping the overall profile low enough to pass through standard-sized insertion sheaths.
Data Source
AI summary
An angioplasty balloon (1) comprises an elongate tube (16) having a relaxed delivery configuration and an expanded deployed configuration. The elongate tube (16) comprises a proximal neck portion (10), a distal neck portion (8), a main body region, a tapered proximal portion (11) extending between the main body region and the proximal neck portion (10); and a tapered distal portion (9) extending between the main body region (3) and the distal neck portion (8), the elongate tube has only three fins (4, 5, 6) which are integrally formed with the tube and which are spaced equidistant from one another about the exterior of the tube. The fins (4, 5, 6) project radially outwardly from the exterior surface of the tube and the fins (4, 5, 6) extending longitudinally only along part of the main body region (3), resulting in the end-sections of the balloon main body being fin-free.