Balloon Folding Control Mechanism for Catheter Creasing Reduction

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Solution Overview

Problem

Conventional balloon catheters with non-elastomeric materials face issues such as transverse creasing and bowing during inflation and deflation, which can hinder medical procedures like angioplasty and photodynamic therapy due to incomplete expansion and improper alignment, and struggle to refold into their initial configuration for easy removal.

Innovation Solution

A slip joint balloon catheter design with a balloon affixed at only one location, featuring a stiffening member and a slip joint connection that allows axial movement, combined with a balloon folding control mechanism to promote refolding into a 3-wing configuration upon deflation, minimizing creasing and facilitating easy insertion and removal.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Volume of moving object

If the balloon is inflated to expand the body canal, then the interior volume of the body canal is enlarged, but the catheter bows due to compressive forces

Engineering Contradiction:
Improveinterior volume of body canalVSAvoidcatheter alignment
Core Design Contradiction:
Volume of moving objectVSShape

Solution Approach 1:

The balloon is designed with dynamic folding characteristics that allow it to change shape during inflation and deflation. The balloon folds during deflation and unfolds during inflation, adapting its shape to maintain catheter alignment while expanding the body canal volume.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The balloon structure is segmented into foldable sections that can independently adjust during inflation and deflation. This segmentation allows the balloon to maintain proper catheter alignment while providing the necessary volume expansion for the medical procedure.

Inventive Principle:
Principle #1Segmentation

2Ease of operation

If the balloon is deflated to pass through the body, then the device can be inserted and removed easily, but the balloon forms transverse creases that prevent full expansion

Engineering Contradiction:
Improveinsertion and removalVSAvoidballoon expansion uniformity
Core Design Contradiction:
Ease of operationVSManufacturing precision

Solution Approach 1:

The balloon employs dynamic folding mechanisms that control how the balloon collapses during deflation. The folding design directs the collapse into controlled patterns that minimize crease formation, allowing the balloon to maintain its structural integrity and expansion uniformity when reinflated.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The balloon is pre-formed with specific folding characteristics during manufacturing that predispose it to fold in controlled patterns during deflation. This preliminary structuring prevents random crease formation and ensures uniform expansion upon reinflation.

Inventive Principle:
Principle #10Preliminary action

3Stability of the object's composition

If the balloon is made from non-elastomeric material, then the balloon maintains structural stability, but the balloon cannot refold into initial configuration

Engineering Contradiction:
Improveballoon structural stabilityVSAvoidrefolding capability
Core Design Contradiction:
Stability of the object's compositionVSDuration of action of moving object

Solution Approach 1:

The non-elastomeric balloon is designed with dynamic folding characteristics that enable it to change shape during inflation and deflation cycles. The folding design allows the rigid material to adapt its configuration without compromising structural stability, enabling refolding into the initial shape.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The balloon incorporates curved and rounded geometric features that facilitate folding and refolding. The spherical or spheroidal shape allows the non-elastomeric material to bend and fold smoothly while maintaining structural integrity, enabling the balloon to return to its initial configuration.

Inventive Principle:
Principle #14Spheroidality (Curvature)

4Measurement precision

If the balloon is inflated under low pressure for PDT, then the catheter is aligned and stabilized, but the balloon does not expand enough to prevent tissue compression

Engineering Contradiction:
Improvecatheter alignmentVSAvoidtissue compression prevention
Core Design Contradiction:
Measurement precisionVSStrength

Solution Approach 1:

The balloon is designed with dynamic expansion characteristics that allow it to achieve sufficient expansion at low pressures. The folding design enables the balloon to expand efficiently, providing both alignment stability and adequate tissue compression prevention without requiring high inflation pressures.

Inventive Principle:
Principle #15Dynamics

Data Source

PatentEP2173427B1Balloon folding control mechanism
Publication Date: 2011.11.30 COOK MEDICAL TECHNOLOGIES LLC
  • EP2173427B1 patent drawingFigure 1A~1D
  • EP2173427B1 patent drawingFigure 2
  • EP2173427B1 patent drawingFigure 3~4

AI summary

A balloon catheter (100) including an inflatable balloon affixed to a catheter. A stiffening member extends distally of the distal end of the catheter and forms a slip joint connection with the distal end of the balloon to permit the distal end of the balloon to axially move or translate relative to the distal end of the catheter. The slip joint allows the axial length of balloon to change during inflation or deflation without transferring tensile or compressive forces between the balloon and the catheter. A balloon folding control mechanism (130) is disposed about the portion of the stiffening member traversing the interior of the balloon, and is configured to promote refolding of the balloon into a predetermined and desired folding configuration upon deflation.