Balloon Catheter Coating Volume Control for Restenosis Prevention
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Solution Overview
Problem
Current balloon catheters face challenges in delivering a controlled and optimal amount of pharmacologically active agents to the vascular wall during short-term exposure, with issues such as uneven coating, substance loss during dilation, and uncontrolled dosage, leading to inefficiencies in preventing restenosis.
Innovation Solution
A coating method using a volume measuring system and release device to apply a defined amount of coating solution to the balloon catheter, ensuring precise and reproducible application of active agents, including antiproliferative and anti-inflammatory agents, directly to the vascular wall.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If a coating solution is applied to the balloon catheter during manufacturing, then the active agents can be delivered to the vascular wall, but the coating amount becomes uncontrolled and inconsistent
Solution Approach 1:
The patent applies a coating solution to the balloon catheter surface before the catheter is used in the body. The coating is applied in advance during manufacturing, allowing the active agents to be pre-positioned on the balloon surface where they will be delivered to the vascular wall during the procedure. This preliminary coating action ensures the active agents are ready for controlled release when needed.
2Duration of action of moving object
If the balloon catheter is inflated for a short time to deliver active agents, then the substance transfer is limited, but the dosage becomes uncontrolled and inconsistent
Solution Approach 1:
The patent incorporates a feedback mechanism where the inflation pressure and duration of the balloon catheter are controlled to optimize the transfer of active agents from the coating to the vascular wall. The feedback system monitors the delivery process and adjusts parameters to ensure consistent and controlled dosage release during the limited exposure time, preventing both under-dosing and over-dosing.
3Object-generated harmful factors
If the balloon catheter is used without a stent, then no foreign object remains in the body, but restenosis prevention is insufficient
Solution Approach 1:
The patent uses a balloon catheter with an active agent coating as an intermediary device to deliver pharmacologically active substances to the vascular wall during a brief inflation period. The balloon itself is not left in the body, but it serves as a temporary carrier that mediates the transfer of active agents from the coating to the tissue, providing restenosis prevention without permanent foreign body implantation.
4Reliability
If the balloon catheter is inflated repeatedly to remove occlusion, then the occlusion is effectively removed, but microlesions are caused in the vascular wall
Solution Approach 1:
The patent converts the potentially harmful mechanical trauma from balloon inflation into a beneficial effect by coating the balloon with pharmacologically active agents. The microlesions caused by balloon inflation create increased surface area and enhanced permeability in the vascular wall, which facilitates greater absorption and uptake of the active agents delivered during the procedure, turning the mechanical damage into an opportunity for improved drug delivery.
Data Source
AI summary
The present invention is directed to a method for coating catheter balloons with a defined amount of a pharmacologically active agent, wherein the coating method uses a coating device having a volume measuring device for releasing a measurable amount of a coating solution by means of a dispensing device specifically onto the surface of the catheter balloon.