Stretch Valve Balloon Catheter Safety Mechanism

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Solution Overview

Problem

Conventional balloon catheters lack self-regulating or self-deflating safety features, leading to injuries such as urethral tearing during improper placement or removal, especially due to over-inflation and premature removal, which can result in severe bleeding, infections, and increased healthcare costs.

Innovation Solution

A balloon catheter with a stretch valve mechanism that automatically deflates when over-inflated or when the catheter is pulled out prematurely, preventing further injury and providing a visual indication of improper placement through fluid drainage, thereby preventing urethral tearing and reducing complications.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If the balloon is made with constant wall thickness and fixed to the drainage line, then the balloon maintains structural integrity during normal use, but it cannot prevent tearing of the urethra during improper placement or removal

Engineering Contradiction:
Improveballoon structural integrityVSAvoidurethral tearing injury
Core Design Contradiction:
StrengthVSObject-affected harmful factors

Solution Approach 1:

The balloon wall thickness is changed from constant to variable, with a thinned section created by making longitudinal incisions and removing material. This thinned section allows the balloon to collapse and deflate at a controlled location rather than maintaining uniform structural integrity throughout, preventing urethral tearing during improper placement or removal.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

Material is extracted from the balloon wall by making longitudinal incisions and removing sections of the balloon wall. This creates a predetermined weak point that will collapse first under stress, extracting the harmful function of uniform strength and replacing it with controlled weakness at a specific location.

Inventive Principle:
Principle #2Taking out (Extraction)

2Reliability

If the balloon is designed to require active deflation by syringe or surgical procedure, then the balloon remains inflated to prevent catheter slippage, but it causes severe bleeding and injury when accidentally pulled out prematurely

Engineering Contradiction:
Improvecatheter anchoring stabilityVSAvoidsevere bleeding from urethral tearing
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

A predetermined collapse location is created in the balloon wall before use, through which the balloon can automatically deflate if pulled on during insertion or removal. This preliminary structural modification ensures that if the catheter is accidentally pulled, the balloon will collapse and deflate before causing severe urethral injury, while still maintaining anchoring stability during proper use.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The predetermined weak point in the balloon acts as a safety mechanism that activates before severe injury can occur. When the catheter is pulled during improper placement or removal, the balloon collapses at the weakened section first, cushioning the patient from the harmful effects of premature deflation and preventing severe bleeding.

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

3Stability of the object's composition

If the balloon material has uniform thickness throughout, then the balloon inflates evenly, but it bursts at random locations based on microscopic fractures rather than at a predefined safe location

Engineering Contradiction:
Improveuniform balloon wall structureVSAvoidcontrolled burst location
Core Design Contradiction:
Stability of the object's compositionVSManufacturing precision

Solution Approach 1:

The balloon wall thickness parameter is changed from uniform to non-uniform by creating a thinned section through longitudinal incisions and material removal. This allows the balloon to maintain even inflation while having a predetermined location that will collapse first, providing controlled failure rather than random bursting based on microscopic defects.

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

The stretch valve mechanism effectively prevents urethral injuries by ensuring the balloon does not over-inflate or tear, reducing hospital stays and costs associated with catheter-related complications, and providing a safer, more efficient insertion and removal process.

Implementation Method 1

a hollow stretch valve shaped to permit a fluid to pass therethrough and positioned in the drainage lumen to at least partially slide therein such that in a steady state the stretch valve prevents the inflation fluid from passing through the drainage port and in an over-inflated state the distal sliding portion slides within the drainage lumen to permit the inflation fluid to pass through the drainage port

Methodology Applied
Scientific EffectElastic deformation: Elasticity

Data Source

PatentEP2931353B1Stretch valve balloon catheter
Publication Date: 2019.07.17 PINCHUK LEONARD
  • EP2931353B1 patent drawingFigure 1
  • EP2931353B1 patent drawingFigure 2~3
  • EP2931353B1 patent drawingFigure 4~8

AI summary

A safety balloon catheter includes a stretch valve and a balloon catheter having a proximal catheter end, a balloon defining an interior to be inflated with an inflation fluid, an inflation lumen extending through the shaft to the interior and shaped to convey inflation fluid thereto and from, a second lumen parallel to the inflation lumen, and a balloon drainage port fluidically connecting the balloon 10 interior to the second lumen.