Fetal Tracheal Balloon with Retrieval Thread

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Solution Overview

Problem

Current medical devices for intrauterine tracheal occlusion in treating congenital diaphragmatic hernia face challenges in easy balloon removal, leading to high morbidity and mortality rates due to iatrogenic rupture of membranes and premature birth, especially during unplanned deliveries.

Innovation Solution

A device featuring a balloon with a flexible, elongated extension element that allows for easy removal by the fetus or operator, comprising a balloon body connected to a thread-like extension element that can be manually wound and deflated by applying force, reducing the risk of unintentional deflation and facilitating surgical procedures.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a balloon is used for intrauterine tracheal occlusion, then lung growth is improved, but removal becomes difficult and causes complications

Engineering Contradiction:
Improvelung growthVSAvoidballoon removal
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The balloon device is segmented into two functional parts: an occlusion element (balloon) for lung treatment and a retrieval element (thread) for removal. The thread passes through the balloon structure, allowing the balloon to be collapsed and withdrawn through the fetal mouth and nose, solving the removal difficulty while maintaining occlusion effectiveness

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

A thread acts as an intermediary element connecting the operator to the balloon. This thread serves as a mediator that transmits pulling force from the operator to the balloon, enabling controlled retrieval without direct manipulation of the balloon itself, thus facilitating easy removal while preserving lung growth benefits

Inventive Principle:
Principle #24Intermediary (Mediator)

2Duration of action of moving object

If a balloon is left in the trachea for extended periods, then lung growth is maximized, but the risk of iatrogenic rupture of membranes increases

Engineering Contradiction:
Improveballoon retention timeVSAvoidmembrane rupture risk
Core Design Contradiction:
Duration of action of moving objectVSObject-affected harmful factors

Solution Approach 1:

The thread is pre-positioned through the balloon structure before insertion into the fetus. This preliminary arrangement allows for rapid retrieval if membrane rupture is anticipated, enabling the balloon to remain in place for the optimal treatment duration while providing a safety mechanism for immediate removal to prevent membrane rupture

Inventive Principle:
Principle #10Preliminary action

3Reliability

If a second surgical intervention is required for balloon removal, then complete treatment is achieved, but operating time and morbidity increase

Engineering Contradiction:
Improvetreatment completionVSAvoidoperating time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The retrieval function is extracted from the balloon structure itself through the integrated thread. This allows the balloon to be removed through a simple external pulling action rather than requiring a second surgical intervention, significantly reducing operating time and morbidity while ensuring complete treatment

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The balloon device is designed to be self-retrieving through the thread mechanism. The thread allows the balloon to be pulled back through the fetal airway without requiring complex surgical removal procedures, enabling the device to serve its own removal function and eliminating the need for additional surgical interventions

Inventive Principle:
Principle #25Self-service

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

Significantly reduces the operating time and associated risks by enabling easier balloon removal, minimizing amniotic injury, and allowing the fetus to remove the balloon itself, thereby reducing morbidity and complications in fetal surgery.

Implementation Method 1

The balloon body (1) is filled with a fluid (5) via the mouth of the balloon (3)

Methodology Applied
Scientific EffectFluid pressure: Pressure Increase

Implementation Method 2

The balloon mouth (3) or another part of the balloon system opens when the extension element (4) is pulled with a certain force

Methodology Applied
Scientific EffectMechanical force transmission: Mechanical Force

Data Source

PatentEP3173034B1Device for carrying out organ occlusions, in particular an intra-uterine tracheal occlusion in the treatment of an innate fetal diaphragmatic hernia
Publication Date: 2018.10.17 UNIVSKLINIKUM HALLE SAALE
  • EP3173034B1 patent drawingFigure 1
  • EP3173034B1 patent drawingFigure 2
  • EP3173034B1 patent drawingFigure 3

AI summary

The present invention relates to a device for use in organ occlusions in humans or mammals, in particular for performing intrauterine tracheal occlusion in the treatment of a congenital fetal diaphragmatic hernia, comprising a fluid-fillable balloon body (1) with a balloon shell (2) forming a lumen for receiving the fluid and a balloon mouth (3) for introducing the fluid into the lumen, a separate auxiliary catheter for placing the balloon body (1) into the organ segment to be treated and/or for inflating the balloon body (1) with the fluid, wherein the balloon body (1) is connected to a flexible elongated extension element (4).