Flexible Balloon Blade Pad for Side-Bending Lesion Cutting
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Solution Overview
Problem
Existing angioplasty balloons with blade members are not flexible enough to navigate the complex vasculature, particularly when subjected to side bending, leading to challenges in treating hardened or calcified lesions and increasing the risk of re-stenosis.
Innovation Solution
The design incorporates a polymeric pad with strategically placed flex points and a blade member embedded within, allowing for increased flexibility during both facial and side bending, facilitated by reduced width regions and tapered edges, to enhance the angioplasty balloon's ability to navigate and treat lesions effectively.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If blade members are embedded within polymeric pads that are adhesively secured to an angioplasty balloon, then the blade members can cut, crack or score lesions, but the polymeric pads are not flexible enough when undergoing side bending
Solution Approach 1:
The polymeric pad is divided into multiple regions with different thicknesses: a first region with a first thickness and a second region with a second thickness that is less than the first thickness. This segmentation allows different portions of the pad to have different flexibility characteristics, enabling the pad to flex during side bending while maintaining structural support for the blade member.
Solution Approach 2:
Different regions of the polymeric pad are given different properties through varying thickness. The first region with greater thickness provides enhanced flexibility in specific areas, while the second region with lesser thickness maintains overall pad structure. This local variation in quality allows the pad to accommodate side bending forces without compromising blade member embedding or cutting capability.
2Ease of manufacture
If the polymeric pad has uniform thickness, then manufacturing is simplified, but the pad cannot accommodate facial bending and side bending effectively
Solution Approach 1:
The pad is segmented into multiple thickness regions rather than being uniform. The first region with greater thickness and the second region with lesser thickness are designed to work together to accommodate both facial bending and side bending, providing the flexibility needed for navigation through curved vasculature.
Solution Approach 2:
The pad exhibits local quality variations through its non-uniform thickness profile. The first region with greater thickness provides enhanced flexibility where needed, while the second region with lesser thickness maintains overall structural integrity. This local differentiation enables effective accommodation of multi-directional bending without significantly complicating manufacturing.
3Strength
If the blade member is rigid, then cutting effectiveness is improved, but the blade member cannot flex during navigation through curved vasculature
Solution Approach 1:
The blade member is designed with dynamic flexibility through the polymeric pad's non-uniform thickness structure. The first region with greater thickness allows the blade member to flex during navigation through curved vasculature, while the second region with lesser thickness maintains the blade's structural integrity and cutting effectiveness when needed.
Solution Approach 2:
The blade member embedding region has local quality variations matching the pad's thickness variations. The greater thickness in the first region provides flexibility for navigation, while the lesser thickness in the second region maintains cutting effectiveness. This local differentiation allows the blade to transition between flexible and rigid states as needed during procedure.
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 flexible design reduces trauma to both targeted and adjacent tissues, improves navigation through curved vasculature, and decreases the likelihood of re-stenosis by effectively cutting or scoring lesions.
Implementation Method 1
The polymeric pad includes a first pad flex point aligned with the first blade flex point and a second pad flex point aligned with the second blade flex point
Implementation Method 2
a polymeric pad adapted to be adhesively secured to an outer surface of the inflatable balloon
Data Source
AI summary
A medical device useful for cracking or cutting an intravascular lesion may include a blade member including a first blade segment and a second blade segment separated by a blade flex point. The blade member is embedded within a polymeric pad that mounts the blade member to an inflatable balloon. The polymeric pad may include a pad flex point that aligns with the blade flex point in order to allow side bending.