Scoring Balloon Catheter With Variable Profile for Calcified Lesions
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Solution Overview
Problem
Existing angioplasty medical balloons with rigid blades struggle to effectively incise hardened lesions due to limited flexibility and uniform radial cutting force distribution, posing navigation challenges and inefficiency in treating calcified or hardened arterial blockages.
Innovation Solution
A medical balloon with a varying radial cross-section and scoring members that protrude radially from its exterior surface, providing improved scoring force and enhanced traction, allowing for precise lesion incision and drug transfer.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If rigid blades are used on medical balloons, then cutting capability is improved, but flexibility and navigation ability deteriorate
Solution Approach 1:
The patent replaces rigid blades with a flexible scoring member that has a memory structure, allowing it to conform to the balloon's varying radial cross-section while maintaining cutting capability. The scoring member's flexibility enables it to navigate tortuous vessels without compromising its ability to incise lesions.
Solution Approach 2:
The scoring member is designed to dynamically adapt its shape through elastic deformation, transitioning from a compressed state during navigation to an expanded scoring state during balloon inflation. This dynamic behavior allows the same structure to provide both flexibility during delivery and cutting capability during operation.
2Ease of manufacture
If uniform radial cross-section is used, then manufacturing simplicity is improved, but scoring force concentration deteriorates
Solution Approach 1:
The patent employs a balloon with a varying radial cross-section featuring peaks and valleys, creating an asymmetric geometry that concentrates the scoring force at the peak regions. This asymmetric design allows the scoring member to contact the lesion at specific high-force points rather than distributing force uniformly across the entire circumference.
Solution Approach 2:
The varying radial cross-section creates localized regions of high scoring force at the peaks, while the valleys provide spacing and flexibility. This local quality variation ensures that the scoring action is concentrated where most needed on the lesion while maintaining overall balloon flexibility.
3Length of moving object
If longer cutting members are used, then lesion coverage is improved, but navigation through tortuous vessels deteriorates
Solution Approach 1:
The scoring member is designed as a segmented or flexible structure that can bend and conform to the balloon's varying cross-section. This segmentation allows the scoring member to achieve effective lesion coverage when the balloon is inflated, while maintaining the flexibility needed to navigate tortuous vessels during delivery in its compressed state.
Data Source
AI summary
An example apparatus for treatment of a vessel lesion comprises a catheter shaft; a medical balloon coaxially mounted on the catheter shaft, the medical balloon having a proximal end, a distal end and a body portion between the proximal and the distal end of the medical balloon, the body portion having an exterior surface, where the medical balloon is configured to expand from a deflated condition to an inflated condition, and where the exterior surface, when in its inflated condition, has a varying radial cross-section along a length thereof; and a scoring member having a proximal end, a distal end, and a body portion therebetween, where the body portion of the scoring member is engaged with the exterior surface, and where, when the medical balloon is in the inflated condition, a portion of the scoring member is configured to contact a target site with improved scoring force.