Blunt Plaque Disruption Balloon for Calcified Lesions
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Solution Overview
Problem
Current vascular and cardiac devices, such as cutting balloons and stents, face challenges in effectively treating calcified lesions with minimal risk to patients, including vessel injury and emboli release, due to their bulky design and sharp blades, which also obstruct blood flow and hinder fluoroscopic imaging.
Innovation Solution
The development of stress-applying features with blunt contact regions on expandable structures, such as balloons and stents, that are designed to fracture or disrupt calcified plaque with minimal risk to underlying tissue, improving visualization and perfusion by using rounded, atraumatic surfaces that distribute force evenly.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If cutting balloons or stents with sharp blades are used to disrupt calcified plaque, then plaque disruption effectiveness is improved, but the risk of vessel wall injury and emboli release increases
Solution Approach 1:
Instead of using sharp blades to cut plaque, the invention uses rounded, blunt protrusions that compress and fracture plaque through controlled stress application. This inverts the traditional cutting mechanism into a compressive fracturing mechanism, achieving plaque disruption without the harmful cutting effects that cause vessel injury and emboli release
Solution Approach 2:
The invention converts the potentially harmful sharp cutting action into a beneficial compressive force. The rounded protrusions apply focused compression to fracture plaque while the surrounding compliant material distributes stress away from the vessel wall, transforming the harmful cutting effect into a safe compressive fracturing effect
2Reliability
If cutting balloons are used to fracture calcified lesions, then plaque disruption is improved, but device bulkiness increases limiting deliverability
Solution Approach 1:
The cutting balloon structure is segmented into multiple discrete rounded protrusions distributed across the balloon surface. This segmentation allows each protrusion to be small and compliant while collectively providing comprehensive plaque disruption coverage, enabling the device to remain compact and deliverable
Solution Approach 2:
The invention changes the physical parameters of the plaque-disrupting features from sharp, rigid blades to rounded, compliant protrusions. This parameter change reduces the overall device bulkiness and improves flexibility while maintaining plaque disruption effectiveness through controlled compression and fracturing
3Manufacturing precision
If higher inflation pressures are applied during post-dilation to ensure good stent apposition, then stent apposition is improved, but vessel wall injury and emboli release increase
Solution Approach 1:
The device incorporates a layer of compliant material between the plaque-disrupting protrusions and the vessel wall that acts as a cushion. This cushioning layer absorbs and distributes the stress during high-pressure inflation, protecting the vessel wall from injury and preventing emboli release while maintaining effective stent apposition
Solution Approach 2:
The device exhibits local quality differentiation where the protrusions provide focused stress concentration for plaque fracture, while the surrounding compliant material provides stress distribution and vessel wall protection. This local quality variation allows high inflation pressures to be applied safely without compromising stent apposition quality
4Reliability
If cutting blades are used to disrupt plaque, then plaque fracture effectiveness is improved, but device complexity and bulkiness increase
Solution Approach 1:
The device uses homogeneous rounded protrusions made from the same compliant material as the balloon matrix, rather than incorporating separate sharp cutting elements. This homogeneity simplifies device construction and reduces complexity while maintaining effective plaque fracture through uniform compressive stress application
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
These features allow for effective disruption of calcified lesions with reduced risk of vessel injury and improved blood flow, enhancing the efficacy of angioplasty and valvuloplasty procedures while maintaining low friction and deliverability through vascular structures.
Implementation Method 1
the outer surface is configured to be displaced radially outwardly toward an inner surface of the vessel wall... configured to fracture or disrupt calcified plaque
Data Source
AI summary
Balloon catheters, sleeves, cages, and endoluminal prostheses are provided with stress-applying and spacing features coupled to expandable surfaces thereof. The stress-applying features may have blunt and/or rounded contact regions which contact tissue or calcified regions in the vasculature. The contact regions dent or fracture occlusive material on the wall of a vascular lumen and/or patient valve leaflets when expanded. The spacing features permit blood, drug, and contrast perfusion past structures expanded in the vasculature, particularly balloon catheters.