Dynamic Tracheal Sealing Balloon With Rapid Flow Compensation

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Solution Overview

Problem

Existing tracheal sealing devices fail to maintain a continuous seal during a patient's breathing cycle due to pressure fluctuations, leading to inefficiencies in sealing performance, particularly at subatmospheric pressures, and lack a mechanism for rapid, synchronous adjustment to thoracic pressure changes.

Innovation Solution

A device with a balloon-like film body that dynamically adapts to organ motility, featuring a flow connection with an extracorporeal control device, optimized for laminar flow and rapid pressure equalization, using a connector and flexible, kink-resistant tubing to maintain seal integrity.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a balloon-like element is used to seal the trachea, then sealing is achieved, but pressure fluctuations during breathing cause the seal to fail

Engineering Contradiction:
Improvesealing performanceVSAvoidpressure stability
Core Design Contradiction:
ReliabilityVSStability of the object's composition

Solution Approach 1:

The balloon element is designed to be dynamically adjustable in volume and pressure, allowing it to adapt to intrathoracic pressure fluctuations during the breathing cycle. The control device modifies the balloon's inflation state in real-time to maintain sealing contact with the tracheal wall despite changing external pressures.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

A pressure sensor provides continuous feedback about the intraluminal pressure within the balloon, which is fed to the control device. This feedback loop enables the control device to automatically adjust the balloon volume and pressure to compensate for breathing-induced pressure changes, ensuring continuous sealing.

Inventive Principle:
Principle #23Feedback

2Reliability

If the balloon volume is increased to maintain seal at higher pressures, then sealing is improved, but the balloon becomes too large during inspiration

Engineering Contradiction:
Improvesealing performanceVSAvoidballoon volume
Core Design Contradiction:
ReliabilityVSVolume of moving object

Solution Approach 1:

The balloon volume is dynamically adjusted based on the phase of the breathing cycle. During inspiration when intrathoracic pressure drops, the balloon volume is increased to maintain sealing contact. During expiration when pressure rises, the balloon volume is reduced to prevent overexpansion, thus maintaining optimal sealing without excessive volume at any given time.

Inventive Principle:
Principle #15Dynamics

3Device complexity

If conventional flow connections are used, then device simplicity is maintained, but pressure equalization is too slow to respond to breathing changes

Engineering Contradiction:
Improveflow connection designVSAvoidpressure equalization speed
Core Design Contradiction:
Device complexityVSSpeed

Solution Approach 1:

The flow connection is designed with optimized geometric parameters including larger diameter, smoother transitions, and minimal length to reduce flow resistance. These parameter changes enable rapid pressure equalization and volume adjustment in response to breathing-induced pressure fluctuations, achieving response times compatible with the breathing cycle.

Inventive Principle:
Principle #35Parameter changes

4Reliability

If high pressure is applied to maintain seal, then sealing effectiveness improves, but tissue damage risk increases

Engineering Contradiction:
Improvesealing effectivenessVSAvoidtissue damage risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The balloon pressure is dynamically adjusted to match the instantaneous intrathoracic pressure plus a small gradient. During inspiration when pressure drops, the balloon pressure is reduced accordingly. During expiration when pressure rises, the balloon pressure is increased to maintain sealing. This dynamic adaptation ensures adequate sealing effectiveness while preventing excessive pressure that could cause tissue damage.

Inventive Principle:
Principle #15Dynamics

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 device ensures a continuous seal with minimal latency, maintaining pressure stability within 20-40 mbar across breathing cycles, reducing turbulence and ensuring effective sealing against secretions.

Implementation Method 1

fluctuations in the balloon volume, which are caused by fluctuations in the intrathoracic pressure due to breathing mechanics, are to be compensated with the smallest possible time latency by supplying volume from an extracorporeal reservoir

Methodology Applied
Scientific EffectPressure equalization: Pressure Gradient

Implementation Method 2

optimized for laminar flow and rapid pressure equalization

Methodology Applied
Scientific EffectLaminar flow: Laminar Flow

Data Source

PatentEP4034208B1Flow-optimised supply to a balloon element that seals dynamically and in sync with organs
Publication Date: 2025.08.13 ADVANCED MEDICAL BALLOONS GMBH
  • EP4034208B1 patent drawingFigure 1~2b
  • EP4034208B1 patent drawingFigure 3a~3b
  • EP4034208B1 patent drawingFigure 4a~4b

AI summary

The invention relates to a device for the dynamically adapting sealing of an organ or a body cavity, e.g. the windpipe (trachea) of an intubated and ventilated patient, wherein the sealing balloon element is produced via particularly rapid shifting of filling medium from an extracorporeal reservoir or an extracorporeal source to the sealing balloon, and wherein, in the dynamic sealing of the trachea according to the example case, a balloon-type foil body preferably formed with residual material in the diameter, i.e. exceeding the tracheal diameter, is in contact with the inner wall of the trachea in a sealing manner and with a pressure that is as constant as possible, wherein fluctuations in the balloon volume, caused by fluctuations in the intrathoracic pressure relating to the mechanics of breathing, are compensated as quickly as possible by supplying volume from an extracorporeal reservoir or an extracorporeal source, and the tracheal secretion sealing of the balloon is thereby kept continuous. This is both made possible by a sufficiently high-volume supply of the balloon filling medium to the cuff, and also prevents steps, gaps or ridges in the supply system, whereby volume flow directed towards the balloon can be minimised, which is crucial for a rapid-as-possible stabilising of the filling volume in the balloon, in particular with small pressure differences between 15 and 30 mbar that are driving the volume flow.