Balloon Catheter Shaft with Expandable Coil for Marker Alignment
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Solution Overview
Problem
Current balloon catheters face challenges in achieving precise alignment of radiopaque markers with the working surface during angioplasty procedures due to misalignment issues caused by tolerance stack-ups and balloon expansion, leading to potential geographic misses during target area contact.
Innovation Solution
Incorporating expandable elements, such as tension coil springs, within the catheter shaft to allow controlled longitudinal expansion, ensuring radiopaque markers align with the balloon's working surface upon inflation, and using these springs as radiopaque identifiers for enhanced visibility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If radiopaque marker bands are attached to the catheter shaft to indicate the working surface position, then the physician can locate the balloon position, but misalignment occurs between the markers and the working surface due to tolerance stack-ups and shaft flexion during inflation
Solution Approach 1:
A radiopaque identifier is attached to the balloon itself rather than the catheter shaft, serving as an intermediary that moves with the balloon during inflation. This eliminates the misalignment problem between fixed shaft markers and the movable working surface, as the identifier maintains its relative position to the working surface throughout the inflation process.
Solution Approach 2:
The radiopaque identifier is integrated directly onto the balloon structure, merging the marking function with the balloon itself. This ensures that the identifier and the working surface move together as a single unit, maintaining accurate alignment regardless of shaft flexion or tolerance variations.
2Illumination intensity
If X-ray contrast agent is used to inflate the balloon for visibility under X-ray, then better visibility is achieved, but inflation and deflation times are prolonged and iodine exposure risk increases
Solution Approach 1:
The balloon incorporates a radiopaque identifier that appears bright under X-ray imaging, providing visibility without requiring contrast agent inflation. This allows the balloon to be inflated with standard saline or other fluids, eliminating the time-consuming contrast agent injection and reduction phases while maintaining adequate radiographic visibility for procedure guidance.
3Volume of moving object
If the balloon is designed with large volume for effective treatment, then treatment efficacy is improved, but inflation and deflation times increase significantly
Solution Approach 1:
The radiopaque identifier provides continuous visibility during the inflation process, allowing the physician to monitor balloon expansion in real-time and stop inflation at the optimal moment. This eliminates the need to over-inflate and then deflate to check position, significantly reducing the time required for large-volume balloon procedures while maintaining treatment efficacy.
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
This solution enhances precision in locating the balloon's working surface, reducing the risk of misalignment and geographic misses, while allowing for efficient inflation and deflation processes without increasing complexity or cost, and can be applied to existing catheter technologies.
Implementation Method 1
a first spring (32a) positioned in tandem with a first, proximal portion (24a) of a structure supporting the balloon (12)... and a second, intermediate portion (24b) of the shaft (24)
Data Source
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Figure 5
AI summary
A balloon catheter comprises a shaft extending in a longitudinal direction and adapted for expanding from a compressed condition to an expanded condition in the longitudinal direction, the shaft supporting at least one radiopaque identifier, and an inflatable balloon positioned along the shaft, the balloon when inflated including a working surface for aligning with the radiopaque identifier in at least the expanded condition of the shaft. Related aspects are also disclosed.