Segmented Pleated Balloon Catheter Sleeve for Atraumatic Dilation
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Solution Overview
Problem
Conventional balloon catheters cause significant trauma to hollow organs during dilation, leading to vessel wall damage, clots, and excessive vessel wall reactions, which can result in renewed constrictions and complications such as intimal hyperplasia, even with the use of stents and antiproliferative coatings.
Innovation Solution
A balloon catheter device with a tubular functional sleeve that unfolds in a segmented, cushion-like manner, featuring planar sections and struts with through-openings, connected to the balloon membrane, ensuring even force distribution and reduced trauma, while allowing for the simultaneous application of a medical agent through openings and pores.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Force
If high pressure balloon dilation is used to treat constrictions in hollow organs, then the constriction is effectively dilated, but significant trauma is caused to the vessel wall leading to ruptures, clots, and excessive wall reactions
Solution Approach 1:
The balloon surface is segmented into multiple discrete cushion elements rather than a continuous surface. Each cushion element independently contacts and dilates a specific segment of the vessel wall, distributing the dilation force across multiple localized contact points. This segmentation prevents concentrated trauma while achieving effective dilation of the constriction.
Solution Approach 2:
The balloon is designed with non-uniform local properties: soft compliant cushion elements for atraumatic contact with the vessel wall, versus a structurally reinforced backbone providing overall shape stability and pressure transmission. This local quality differentiation allows the balloon to exert controlled dilation force while minimizing wall trauma through the compliant cushion surfaces.
2Quantity of substance
If a homogeneous film-like coating with antiproliferative agent is applied to the balloon, then the coating provides therapeutic effect, but it does not ensure uniform distribution of the active substance to the vessel wall
Solution Approach 1:
The homogeneous film-like coating is segmented into multiple discrete reservoir elements that correspond to the cushion elements. Each reservoir contains antiproliferative agent and is positioned to release the substance at a specific location on the vessel wall during dilation. This segmentation ensures uniform spatial distribution of the active substance across the treated area, preventing localized overdosing or underdosing.
Solution Approach 2:
The reservoir elements act as intermediaries between the antiproliferative agent and the vessel wall. Each reservoir controls the release of active substance directly at the site of cushion contact, ensuring precise and uniform delivery of the therapeutic agent to the vessel wall segments being dilated.
3Stability of the object's composition
If stents are implanted to permanently widen the vessel, then the vessel remains open, but the stent rigidity blocks natural pulsatile motility and causes excessive vessel wall cell production and new constriction formation
Solution Approach 1:
The balloon catheter system is designed as a dynamic, temporary intervention rather than a static permanent implant. The balloon provides temporary mechanical support during dilation, then is completely removed after treatment. This dynamic approach allows the vessel to maintain natural pulsatile motility post-treatment while preventing the formation of new constrictions through localized antiproliferative therapy, avoiding the intimalhyperplasia problem associated with permanent stents.
4Reliability
If the balloon sleeve is coated with antiproliferative agent transferred during dilation, then therapeutic effect is achieved, but the coating does not provide controlled release over the critical period of 6 weeks to 3 months
Solution Approach 1:
The antiproliferative agent is pre-loaded into reservoir elements on the balloon surface before the procedure. During dilation, the reservoirs are activated and begin controlled release of the active substance. This preliminary preparation ensures that the therapeutic agent is available in controlled quantities throughout the critical 6-week to 3-month period when intimalhyperplasia risk is highest, providing reliable and sustained therapeutic effect.
Data Source
AI summary
According to the invention, a balloon catheter device for the atraumatic treatment of hollow organs is provided. It comprisesa balloon catheter with a balloon,a tubular functional sleeve applied to the balloon for the directed segmented cushion-like unfolding of the balloon for the dilation of a hollow organ and simultaneous application of active substance into the hollow organ wall, and whereinthe functional sleeve is folded in an initial state together with the balloon about a sleeve longitudinal axis, and wherein the folding of the functional sleeve is directed as pleating about a sleeve longitudinal axis and in a final state is unfoldable for abutting against an inner wall of a hollow organ, and wherein the tubular functional sleeve has planar sections and/or planar struts which delimit through-openings, so that the functional sleeve is used for sectional limitation of a balloon dilation of the balloon.