Balloon Catheter Coating with Shellac Ammonium Salt
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Solution Overview
Problem
Current balloon catheter coatings with shellac fail to achieve optimal bioavailability and therapeutic effect for reducing restenosis due to inefficient release kinetics, with shellac-based coatings releasing drugs too slowly and coatings using organic solvents posing handling and stability issues.
Innovation Solution
A catheter balloon coating comprising a water-soluble shellac salt, preferably shellac ammonium salt, combined with an active agent like paclitaxel or sirolimus, which enhances the transfer of the active agent to the vessel wall, achieving a higher concentration and improved bioavailability by using an aqueous solution to create a stable and effective coating.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of moving object
If shellac-based coating is used on catheter balloon, then the coating provides drug delivery capability, but the release kinetics are too slow to achieve optimal therapeutic effect
Solution Approach 1:
The patent changes the chemical parameter of the shellac coating by using shellac ammonium salt instead of traditional shellac, and by controlling the pH value (6.5-7.5) and water content (5-20%) of the coating solution, thereby optimizing the drug release kinetics to achieve both sustained release and high therapeutic efficacy
2Ease of manufacture
If organic solvent-based coating is used, then the coating can be applied to the balloon, but handling and stability issues arise
Solution Approach 1:
The patent changes the fundamental parameter of the coating solution from organic solvent-based to water-based, using shellac ammonium salt which is soluble in aqueous solutions at pH 6.5-7.5, thereby eliminating the handling and stability issues associated with organic solvents while maintaining coating applicability
Solution Approach 2:
The patent introduces shellac ammonium salt as an intermediary substance that bridges the compatibility between water-based solutions and effective drug delivery, allowing the use of safe aqueous carriers while achieving reliable therapeutic outcomes
3Quantity of substance
If pure paclitaxel coating is applied to catheter balloon, then the drug can be delivered, but no therapeutic effect is achieved
Solution Approach 1:
The patent creates a composite coating material consisting of shellac ammonium salt and paclitaxel, where the shellac ammonium salt matrix enables controlled release and enhanced penetration of paclitaxel into the vessel wall, transforming the ineffective pure drug coating into a therapeutically active system
Solution Approach 2:
The shellac ammonium salt acts as a mediator that facilitates the penetration and effectiveness of paclitaxel in the vessel wall, enabling the drug to achieve therapeutic effects that were not possible with direct application
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 'Shellaqua' coating significantly increases the amount of active agent transferred during balloon inflation, achieving higher concentrations in the vessel wall and reducing restenosis, with improved mechanical properties and stability compared to traditional shellac-based coatings, leading to enhanced therapeutic efficacy and reduced risk of thrombosis.
Implementation Method 1
The solution is applied to the surface of a catheter balloon and the solvent is evaporated
Implementation Method 2
a sufficient amount of pharmacological agent is transferred to the vessel wall to avoid re-constriction or reocclusion of the vessel due to the dilatation of the vessel and the delivery of active agents
Data Source
Figure 1
AI summary
The present invention relates to balloon catheter coated with an active agent and a shellac alkali salt, preferably shellac ammonium salt. Moreover the present invention relates to a method for coating catheter balloons with a pharmacological active agent and an aqueous solution of shellac.