Pleated Catheter Balloon for Predictable Folding

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Solution Overview

Problem

Conventional balloon-mounted catheters for renal denervation procedures face challenges with insertion and withdrawal due to random, non-deterministic folding, requiring excessive force and complicating the process, especially when navigating through guide catheters.

Innovation Solution

The catheter-mounted balloon is designed to pleat in a predictable pattern through thermal, mechanical, or chemical means, reducing the force required for insertion and withdrawal, and allowing for lower inflation pressure and potentially smaller catheter sizes by configuring pleats to maintain an opening between sides when deflated.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If a conventional balloon is used without pre-pleating, then the balloon can be simply manufactured, but the force required to insert or withdraw the balloon through the catheter greatly increases

Engineering Contradiction:

Improveballoon manufacturing simplicityVSAvoidforce required for balloon insertion and withdrawal

Core Design Contradiction:

Ease of manufactureVSForce

Solution Approach 1:

The balloon is pre-pleated during manufacturing to create predetermined fold patterns that will automatically unfold during insertion and refold during withdrawal. This preliminary structuring eliminates the need for random folding during use, significantly reducing the force required for catheter navigation while maintaining manufacturing feasibility through specialized molding or thermal processes

Inventive Principle:

Principle #10Preliminary action

2Device complexity

If a non-pleated balloon is used, then the catheter structure remains simple, but the balloon forms tight random non-deterministic folds that complicate insertion and withdrawal

Engineering Contradiction:

Improvecatheter structural simplicityVSAvoidease of balloon insertion and withdrawal

Core Design Contradiction:

Device complexityVSEase of operation

Solution Approach 1:

The balloon surface is segmented into multiple pleats or folds that are predetermined during manufacturing. These segmented structures guide the balloon to fold in specific, predictable patterns rather than forming random tangles, making insertion and withdrawal significantly easier while adding only moderate complexity to the catheter design

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Inventive Principle:

Principle #10Preliminary action

3Stress or pressure

If looser pleats are used to reduce inflation pressure, then the inflation pressure requirement decreases, but the balloon may require more space when deflated

Engineering Contradiction:

Improveinflation pressure requirementVSAvoiddeflated balloon volume

Core Design Contradiction:

Stress or pressureVSVolume of moving object

Solution Approach 1:

The pleat geometry parameters (depth, width, spacing, and configuration) are optimized to achieve the desired balance between inflation pressure reduction and deflated volume. By adjusting these parameters, the balloon can be designed to require lower inflation pressures while maintaining a compact deflated profile suitable for catheter delivery

Inventive Principle:

Principle #35Parameter changes

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 design reduces the force needed for balloon deployment and retrieval, facilitates easier navigation through guide catheters, and allows for more efficient renal denervation procedures with reduced pressure requirements and potential for smaller punctures during minimally invasive surgery.

Implementation Method 1

pleating a catheter-mounted balloon (e.g., by thermal, mechanical, or chemical means), such that the balloon preferentially folds in a predictable pattern along the pleat lines when collapsed

Methodology Applied

Scientific EffectFolding: Folding

Implementation Method 2

pleating a catheter-mounted balloon (e.g., by thermal, mechanical, or chemical means)

Methodology Applied

Scientific EffectThermal heating: Heating

Implementation Method 3

the pleats may be configured such that inflation of the balloon requires less pressure than in a typical system

Methodology Applied

Scientific EffectPressure reduction:

Data Source

PatentUS10987494B2Pleated or folded catheter-mounted balloon

Publication Date: 2021.04.27 COVIDIEN LP

AI summary

A catheter-mounted balloon includes an inflatable chamber defining a volume expandable from a deflated state to an inflated state, the inflatable chamber having a distal transition portion, a proximal transition portion, and a cylindrical body portion disposed between the distal transition portion and the proximal transition portion. The cylindrical body portion of the inflatable chamber includes a pleat zone having a pleat when the inflatable chamber is in the deflated state. The catheter-mounted balloon further includes an electrode disposed along a wall of the inflatable chamber. The pleat traverses the electrode such that is electrode is pleated as well.