Coated Balloon Catheter Using PEG-PVA Binder for Drug Stability
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current balloon catheters with drug coatings face issues of non-uniform active ingredient distribution and stability, leading to inadequate drug delivery due to detachment during transport to the stenosis site, despite the use of multi-layer systems for adhesion.
Innovation Solution
A balloon catheter coating using a polyethylene glycol-polyvinyl alcohol copolymer (PEG-PVA) binder matrix, optionally with shellac, ensures a stable and uniform distribution of anti-proliferative drugs like paclitaxel, with controlled release through selective solvent selection and structuring, eliminating the need for a top cover layer.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a multi-layer coating system with adhesion layers and cover layers is applied to improve coating stability, then coating stability is improved, but device complexity and insufficient drug delivery occur
Solution Approach 1:
The patent removes the cover layer from the multi-layer coating system, extracting only the essential adhesion layer and drug-containing layer. This simplification maintains coating stability while eliminating the complexity and drug delivery barriers introduced by the cover layer.
Solution Approach 2:
The patent uses a composite binder matrix comprising shellac and gelatin that provides both adhesion and structural stability functions previously requiring separate layers. This composite material approach achieves coating stability without the need for multiple discrete layers.
2Reliability
If a cover layer is applied to protect the active substance layer, then coating stability is improved, but drug delivery to the vessel wall becomes insufficient
Solution Approach 1:
The patent completely removes the cover layer from the coating system, eliminating the barrier that prevented sufficient drug delivery. The extracted design relies on the adhesion layer and binder matrix to provide stability without compromising drug transfer to the vessel wall.
Solution Approach 2:
The patent modifies the binder matrix composition (shellac and gelatin ratio, crosslinking degree) to achieve the required stability without a cover layer, changing the physical-chemical parameters of the remaining layers to compensate for the removed protective layer.
3Ease of operation
If the balloon catheter is inserted into vessels for transport to the stenosis site, then the treatment function is enabled, but considerable loss of active substance occurs due to coating detachment
Solution Approach 1:
The patent applies an adhesion layer before the drug-containing layer, creating a stable foundation that prevents coating detachment during catheter insertion and transport. This preliminary structural preparation ensures the drug layer remains intact until it reaches the target site.
Solution Approach 2:
The patent employs a composite binder matrix of shellac and gelatin that provides enhanced mechanical stability and adhesion during catheter manipulation and insertion, preventing premature drug release while maintaining ease of catheter deployment.
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
The PEG-PVA copolymer binder matrix provides mechanical stability and controlled release of the active substance, minimizing detachment during insertion and ensuring effective drug delivery at the stenosis site, even with short contact times.
Implementation Method 1
The binder matrix consists of a polyethylene glycol-polyvinyl alcohol copolymer (PEG-PVA copolymer) and optionally shellac
Implementation Method 2
enables controlled active substance delivery to the vessel wall at the site of the stenosis
Implementation Method 3
provides mechanical stability and controlled release of the active substance, minimizing detachment during insertion
Data Source
Figure 1~2
AI summary
The invention relates to a coated balloon catheter comprising a catheter substrate and a coating on the catheter substrate. The coating comprises a pharmaceutically active ingredient embedded in a binder matrix. The binder matrix consists of a polyethylene glycol-polyvinyl alcohol copolymer (PEG-PVA copolymer) and optionally shellac or a shellac derivative and other pharmaceutically compatible excipients. A composition for coating the balloon catheter comprises the pharmaceutically active ingredient and a binder consisting of a PEG-PVA copolymer and optionally shellac or a shellac derivative. The active ingredient and the binder are dissolved in a solvent mixture consisting of water, DMSO, and at least one other organic solvent that is miscible with water in unlimited quantities.