Folded Catheter Balloon Coating for Uniform Drug Distribution
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Solution Overview
Problem
Current methods for coating percutaneous transluminal angioplasty (PTA) balloon catheters are inconsistent, nonuniform, labor-intensive, and environmentally unfriendly, leading to high restenosis rates and systemic drug dosages, necessitating improved therapies for vascular disease treatment.
Innovation Solution
A method involving metered and consistent coating of PTA catheter balloons using a specifically-sized protective sheath, optimized folding configurations, and controlled application of therapeutic agents within the balloon folds, combined with techniques like vacuum coating and intermediate layers, ensures uniform distribution and retention of therapeutic agents.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If dip coating method is used to coat PTA catheter balloons, then the coating process is simple, but the coating is inconsistent, nonuniform, and shreds away during handling
Solution Approach 1:
The balloon is divided into multiple folds (typically 3-5 folds) to create a structured configuration that allows for more controlled and uniform coating application. Each fold acts as a separate segment that can be coated individually, ensuring consistent drug distribution across the entire balloon surface while maintaining coating integrity during handling.
Solution Approach 2:
The balloon is pre-folded into a specific configuration before the coating process. This preliminary folding creates defined surfaces and edges that guide the coating solution flow, ensuring uniform distribution of the therapeutic agent. The pre-folded structure also prevents coating from shredding during subsequent handling by establishing a stable geometric framework.
2Productivity
If standard coating methods are used, then the manufacturing process is quick, but the coating delivery is inconsistent and requires higher dosages
Solution Approach 1:
The balloon surface is segmented into multiple folds, each serving as a discrete coating compartment. This segmentation allows the coating solution to be distributed more uniformly across each fold surface, ensuring consistent drug delivery. The segmented structure maintains coating integrity while enabling controlled drug release at the target site.
Solution Approach 2:
Each fold of the balloon is designed with specific geometric characteristics (depth, width, surface area) that are optimized for uniform coating distribution. The local geometry of each fold ensures that the therapeutic agent is distributed consistently across the coating surface, providing reliable drug delivery without requiring excessive dosages.
3Reliability
If higher dosages of therapeutic agents are used to ensure effective coating, then treatment effectiveness is improved, but systemic drug exposure and side effects increase
Solution Approach 1:
The therapeutic agent is segmented into multiple discrete folds of the balloon, creating localized drug reservoirs. This segmentation ensures that the drug is delivered precisely to the target site (the balloon surface that contacts the vessel wall) rather than being systemically distributed. The segmented coating structure maintains drug concentration at effective levels locally while minimizing systemic exposure.
Solution Approach 2:
The coating design concentrates the therapeutic agent specifically at the balloon surface folds that will contact the vessel wall during angioplasty. This localized quality ensures high drug concentration where needed (at the lesion site) while reducing overall drug用量 and systemic exposure. The geometric optimization of each fold maximizes local drug delivery efficiency.
4Adaptability or versatility
If manual coating processes are used, then flexibility in coating application is maintained, but labor intensity and manufacturing time increase
Solution Approach 1:
The balloon is segmented into folds that create a standardized geometric structure, enabling automated coating processes. Each fold acts as a repeatable unit that can be coated using consistent parameters, greatly facilitating automation. The segmented design maintains flexibility in coating application because each fold can be independently coated while following the same standardized procedure.
Solution Approach 2:
The balloon is pre-folded into a standardized configuration before coating, creating a consistent geometric template that simplifies the subsequent coating process. This preliminary action enables automated coating systems to efficiently apply the therapeutic agent to each fold using predetermined parameters, dramatically increasing manufacturing productivity while maintaining coating quality consistency.
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 approach achieves consistent and controlled delivery of therapeutic agents directly to the vascular wall, reducing restenosis rates and systemic drug exposure while minimizing manufacturing costs and environmental impact.
Implementation Method 1
The folded catheter balloon is then coated with a coating solution using any suitable technique, such as dip coating, injection, spraying, or vacuum
Implementation Method 2
The porous intermediate layer provides for adherence of the therapeutic coating to the balloon
Data Source
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AI summary
A method of coating a folded catheter balloon, the method comprising providing a pressure chamber having a coating solution contained therein, wherein the coating solution comprises a therapeutic agent; placing the folded balloon catheter into the coating solution in the pressure chamber, applying a pressure and/or vacuum to force the coating into the folds of the balloon, releasing the pressure and/or vacuum, and removing the folded and coated catheter balloon from the chamber.