Balloon Fold Elements for Catheter Kinking and Shrinkage

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Solution Overview

Problem

Current balloon catheters face challenges such as complex folding processes, dimensional shrinkage, and increased pull-back forces due to anisotropic bending, leading to kinking and inefficient medication delivery, while biodegradable stents struggle with pH changes and uncontrolled corrosion affecting active pharmaceutical substance release.

Innovation Solution

A catheter with a balloon featuring fold elements running in the longitudinal direction, minimizing bending radius, and an intraluminal endoprosthesis securely fixed on the folded balloon, allowing for reproducible folding and controlled medication release.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If traditional compressive forces are applied to fold the balloon, then the balloon can be secured in a folded state, but the process requires high temperatures and long times, and results in shrinkage and dimensional alteration

Engineering Contradiction:

Improvefolding processVSAvoidballoon dimensions

Core Design Contradiction:

Ease of manufactureVSManufacturing precision

Solution Approach 1:

The patent changes the physical-chemical parameters of the balloon material by applying a polymerizable monomer layer that undergoes photopolymerization. This transforms the material properties to enable self-folding through chemical crosslinking rather than mechanical compression, eliminating the need for high temperatures and long times while preserving dimensional accuracy

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent replaces the mechanical folding system (compressive forces, heat treatment) with a chemical system (photopolymerization of monomer layer). The chemical crosslinking process creates permanent folds without mechanical impressing, eliminating dimensional shrinkage and altering the manufacturing approach fundamentally

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

2Ease of manufacture

If the balloon is folded using traditional methods, then it can be secured, but the wing shape is lost and the balloon refolds defectively, requiring increased pull-back force

Engineering Contradiction:

Improvefolding processVSAvoidfold stability

Core Design Contradiction:

Ease of manufactureVSReliability

Solution Approach 1:

The patent modifies the material parameters by applying a photopolymerizable monomer layer that creates permanent crosslinked folds. This chemical modification ensures the balloon maintains its folded wing configuration reliably, preventing defective refolding and reducing pull-back forces during retraction

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent performs preliminary chemical modification (monomer layer application and photopolymerization) before the folding process. This preliminary action creates pre-programmed fold locations that guide the balloon's refolding behavior, ensuring consistent and reliable fold stability without defective refolding

Inventive Principle:

Principle #10Preliminary action

3Device complexity

If wings run parallel to the catheter axis, then the balloon structure is simple, but the catheter is more susceptible to kinking and creates unwanted transverse folding

Engineering Contradiction:

Improveballoon structureVSAvoidcatheter flexibility

Core Design Contradiction:

Device complexityVSReliability

Solution Approach 1:

The patent introduces asymmetric fold patterns where folds are positioned at specific locations rather than uniformly distributed. This asymmetric arrangement optimizes the balance between structural simplicity and resistance to kinking, preventing unwanted transverse folding while maintaining manufacturing efficiency

Inventive Principle:

Principle #4Asymmetry

4Adaptability or versatility

If active pharmaceutical substance is applied to the balloon surface, then medication delivery is enabled, but residues may be released at the wrong time during retraction

Engineering Contradiction:

Improvemediction deliveryVSAvoiduncontrolled substance release

Core Design Contradiction:

Adaptability or versatilityVSObject-affected harmful factors

Solution Approach 1:

The patent applies the active pharmaceutical substance after the fold formation and sealing processes are complete. This preliminary sequencing ensures the medication is only released after the catheter is properly positioned and the balloon is in the correct state, preventing premature release during retraction

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The patent uses the photopolymerized monomer layer as an intermediary barrier between the balloon surface and the active pharmaceutical substance. This intermediary layer controls the release timing, preventing premature leakage while allowing controlled delivery at the appropriate moment during the procedure

Inventive Principle:

Principle #24Intermediary (Mediator)

Data Source

PatentUS9095687B2Catheter, system for inserting an intraluminal endoprosthesis and method for manufacturing same

Publication Date: 2015.08.04 BIOTRONIK AG

AI summary

A catheter having a balloon (10) which has at least one wing (12) in the undilated state, the balloon having at least one fold element (11, 11′, 31, 32, 41, 42) running essentially in the longitudinal direction for each wing (12), such that in folding the balloon (10), the fold element is arranged in an area of the wing (12) with a minimum in the bending radius, said area running in the longitudinal direction. Also disclosed is a system for introducing an intraluminal endoprosthesis, preferably a stent, into a body cavity consisting of an intraluminal endoprosthesis and a catheter having the balloon as described. Further, disclosed are methods of producing such a catheter and such a system.