Segmented Balloon Catheter Coating for Crack Prevention
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Solution Overview
Problem
Balloon catheters with medicine coatings face issues of medicine elution and loss due to cracks forming during deflation and folding, which can lead to unintended medicine delivery outside the target lesion site, causing side effects and reducing therapeutic efficacy.
Innovation Solution
A balloon catheter design featuring a first region with a medicine coating and a second region with less or no medicine, strategically positioned to prevent crack spread and medicine elution, along with manufacturing methods that include forming masks and applying medicine to specific areas to ensure targeted delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If the balloon is uniformly coated with medicine to maximize medicine retention, then the amount of medicine available for treatment is increased, but cracks may spread over the entire balloon causing medicine to fall everywhere
Solution Approach 1:
The balloon surface is divided into multiple segments or zones with different medicine coating densities. The first region has a higher medicine coating density while the second region has a lower medicine coating density or no medicine coating, creating segmented zones that prevent crack propagation across the entire balloon surface.
Solution Approach 2:
Different regions of the balloon surface are assigned different medicine coating qualities. The first region receives a higher concentration or thickness of medicine coating to ensure sufficient drug delivery, while the second region has reduced or no coating to serve as a crack barrier, creating local quality variations that balance therapy and stability.
2Ease of operation
If the balloon is folded with wings wrapped around the shaft to reduce outer diameter, then the deliverability of the catheter is improved, but the medicine layer may develop rifts or cracks
Solution Approach 1:
The balloon is divided into folded wings that wrap around the shaft, creating segmented structural zones. This segmentation allows the balloon to compress to a small diameter for delivery while the segmented medicine coating regions prevent crack propagation during the folding and unwrapping process.
Solution Approach 2:
The medicine coating density varies locally across different regions of the balloon. Regions subject to folding stresses have reduced medicine coating or no coating to prevent crack formation, while regions that will contact the lesion site have higher medicine coating density to ensure effective drug delivery.
3Volume of moving object
If material with high expandability is used for the balloon to reduce deflated diameter, then the deliverability is improved, but the medicine layer may be more susceptible to cracking during inflation
Solution Approach 1:
The balloon material or coating structure varies locally to accommodate different functional requirements. Regions requiring high expandability have appropriate material properties, while regions with medicine coating have modified properties or reduced coating density to prevent cracking during the inflation process from the compressed delivery state to the expanded treatment state.
Data Source
AI summary
A balloon catheter includes a shaft and a balloon having one or more fold lines. The balloon is disposed outside the shaft, and the balloon includes one or more first regions and one or more second regions. The first region retains medicine on an outer surface of the balloon. The second region retains less medicine than the first region or retains no medicine.