Coating Catheter Balloon Folds for Drug Retention
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Solution Overview
Problem
Existing methods for coating catheter balloons with pharmacologically active substances face challenges such as premature detachment of microcapsules and limited applicability to liquids, especially when trying to enclose active ingredients within the folds of the balloon, leading to inconsistent delivery and reduced effectiveness at the treatment site.
Innovation Solution
A method involving the coating or filling of catheter balloon folds with a liquid mixture containing an active substance and a solvent, which can include contrast media, excipients, or other pharmacologically tolerable substances, using a solvent like glycerol or ethanol, and applying it in a compressed state to ensure targeted delivery and retention during expansion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If microcapsules are used to enclose active ingredients on the catheter balloon surface, then the active ingredient can be protected from premature detachment, but only a portion of the microcapsules are enclosed in the folds and the amount of active ingredient is unknown, leading to inconsistent delivery
Solution Approach 1:
The patent utilizes the porous structure of the balloon folds to enclose the active ingredient. The folds create a three-dimensional porous-like structure that traps the active ingredient within its matrix, ensuring complete enclosure and precise dosage control. This resolves the contradiction by providing both protection (through enclosure) and manufacturing precision (through controlled filling of the fold structure).
Solution Approach 2:
The active ingredient is nested within the fold structure of the balloon. The fold creates an internal cavity that completely encloses the active ingredient, similar to a nested doll structure. This ensures that the entire amount of active ingredient is contained within the fold, providing both protection and precise dosage control, eliminating the problem of unknown amounts and inconsistent delivery.
2Quantity of substance
If the catheter balloon is coated with a large surface area of active ingredient, then more drug is available for delivery, but the active ingredient detaches prematurely during insertion
Solution Approach 1:
The patent segments the active ingredient delivery system by dividing it into multiple fold structures along the balloon. Each fold acts as an independent reservoir, allowing the total quantity of active ingredient to be increased while maintaining retention through the segmented enclosure structure. This prevents premature detachment while providing sufficient drug quantity for effective treatment.
Solution Approach 2:
The fold structure creates a porous-like three-dimensional matrix that encloses the active ingredient. This structure provides large surface area for drug availability while the porous enclosure prevents premature detachment during insertion. The active ingredient is trapped within the fold matrix, ensuring retention until the intended delivery site.
3Stability of the object's composition
If a coating method is applied to the entire balloon surface, then uniform distribution is achieved, but the active ingredient is exposed and detaches during catheter insertion
Solution Approach 1:
The fold structure creates a three-dimensional porous-like matrix that provides uniform distribution of the active ingredient throughout the fold volume while simultaneously enclosing it to prevent detachment. The porous structure allows uniform impregnation during the coating process while the fold walls provide retention, resolving the contradiction between uniform distribution and retention.
4Reliability
If microcapsules are used to coat the balloon, then the active ingredient is protected, but the method is limited to solids and cannot be applied to liquids
Solution Approach 1:
The patent changes the physical state parameter of the active ingredient from solid microcapsules to liquid or semi-liquid formulations that can be impregnated into the fold structure. This parameter change allows the method to accommodate different states of matter (solids, liquids, semi-solids) while maintaining the protective and retentive fold enclosure structure, thereby increasing adaptability without sacrificing reliability.
Solution Approach 2:
The fold structure acts as an intermediary medium that can accommodate different states of active ingredient. Instead of requiring the active ingredient to be in microcapsule form, the fold structure serves as a universal container that can hold solids, liquids, or semi-solids, providing both protection and enabling versatility across different pharmaceutical formulations.
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 method ensures consistent and targeted delivery of active substances to the treatment site, preventing premature detachment and maintaining the active ingredient's effectiveness by using a solvent that does not damage the balloon material, allowing for efficient release during balloon dilation.
Implementation Method 1
The folds are filled with a liquid mixture comprising at least one active ingredient and a solvent or a carrier substance
Implementation Method 2
using a solvent like glycerol or ethanol
Data Source
Figure 1~2
AI summary
The present invention relates to a method for filling or coating folds of a catheter fold balloon, in which a delivery device in the form of a syringe, needle or nozzle, which delivers a continuous flow of an active ingredient-containing composition, is moved along the fold relative to the catheter fold balloon, wherein the catheter balloon and the delivery device both move relative to each other, or catheter fold balloons obtainable according to this method.