Cutting Balloon Catheter Frame for Continuous Plaque Disruption
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Solution Overview
Problem
Existing angioplasty balloons struggle to effectively treat hardened or calcified lesions due to their inability to create long, continuous disruptions in plaque, leading to re-stenosis and trauma to healthy tissue.
Innovation Solution
A cutting balloon catheter equipped with an expandable frame and cutting members, such as struts and links, mounted on the balloon to create a long cutting plane when inflated, facilitating plaque disruption and reducing re-stenosis.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional angioplasty balloons are used to treat hardened or calcified lesions, then the procedure is simple, but the balloon cannot create long continuous disruptions in plaque leading to re-stenosis
Solution Approach 1:
The balloon is divided into multiple segments with cutting members positioned at different locations along the balloon circumference. Each segment can independently engage with the plaque, and the cumulative effect of multiple cutting segments creates long continuous disruptions that prevent re-stenosis while maintaining manageable device complexity through modular design
Solution Approach 2:
The cutting members are designed to be dynamically deployable - they remain retracted during balloon delivery and inflation, then extend outward to engage with hardened lesions when the balloon is positioned. This dynamic deployment mechanism enables the balloon to adapt its cutting capability based on the treatment need, improving reliability without permanent structural complexity
2Reliability
If cutting members are added to the balloon to create long cutting planes, then plaque disruption effectiveness improves, but device complexity increases
Solution Approach 1:
The cutting members are merged with the balloon structure by integrating them into the expandable frame that is already part of the angioplasty system. The cutting members share the same deployment mechanism and structural support as the balloon itself, combining multiple functions (balloon inflation, frame expansion, and cutting member deployment) into a single integrated system that reduces overall complexity
Solution Approach 2:
The expandable frame serves multiple functions: it provides structural support for the balloon, enables controlled expansion of the cutting members, and maintains positioning stability during the cutting operation. This multi-functionality reduces the need for separate components, improving reliability while controlling device complexity
3Reliability
If multiple cutting members are positioned along the balloon, then continuous plaque disruption is achieved, but manufacturing complexity increases
Solution Approach 1:
The cutting members are manufactured as separate modular segments that can be independently produced and then assembled along the balloon. Each segment is a discrete component with standardized attachment interfaces, allowing for parallel manufacturing and simplified assembly procedures. This segmentation enables continuous cutting plane creation while maintaining ease of manufacture through modular construction
Solution Approach 2:
An intermediary attachment structure is used to connect the cutting members to the balloon frame, serving as a mediator that simplifies the assembly process. This intermediary component provides standardized mounting interfaces and alignment features, reducing the complexity of positioning and securing multiple cutting members while ensuring reliable continuous cutting capability
Data Source
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AI summary
A cutting balloon catheter including a balloon mounted on a distal portion of a catheter shaft. An expandable frame may be disposed over the balloon. The expandable frame may include a plurality of struts extending from a proximal end region to a distal end region. One or more cutting members may be secured to the expandable frame.