Pre-biased Indicator for Enteral Feeding Catheter Balloon
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Solution Overview
Problem
Existing gastrostomy tubes with inflatable balloons for enteral feeding face challenges in providing a clear and easy-to-read pressure indication, especially at low pressures, due to the size and complexity of conventional pressure indicators, which can lead to inaccurate interpretation and tissue damage from overinflation or underinflation.
Innovation Solution
A balloon catheter device with a pre-biased indicator that provides a discrete visual signal for changes in balloon pressure or volume, using a flexible sleeve and biasing element to move between axial positions, offering a simple and reliable indication of pressure changes at low pressures, such as 4 pounds per square inch or less, without requiring continuous monitoring.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If conventional pressure indicators are used to monitor balloon inflation, then pressure monitoring capability is provided, but the device complexity increases and measurement precision deteriorates at low pressures
Solution Approach 1:
The patent employs a color-changing indicator mechanism where a visible portion changes color or becomes visible when the balloon reaches a predetermined inflation pressure. This optical indication method provides clear, easy-to-interpret visual signals without requiring complex electronic or mechanical pressure gauges, thereby maintaining measurement precision while minimizing device complexity
Solution Approach 2:
The patent extracts only the essential function needed for pressure indication - a simple visual signal that changes at a predetermined pressure threshold - rather than implementing a continuous pressure monitoring system. This extracted function is achieved through a lightweight indicator mechanism coupled to the balloon, providing adequate information without the complexity of full pressure measurement systems
2Reliability
If continuous pressure monitoring is implemented, then inflation status is continuously tracked, but the device complexity and energy consumption increase
Solution Approach 1:
Instead of continuous monitoring, the patent implements periodic or threshold-based indication where the indicator changes state only when the balloon reaches a predetermined pressure level. This approach maintains reliability by providing critical inflation status information at key moments without the continuous operation required by constant monitoring systems, thereby reducing complexity
Solution Approach 2:
The indicator system is designed to automatically change state in response to balloon pressure changes without requiring external power sources, electronic components, or active monitoring. The indicator mechanism self-actuates through the mechanical coupling to the balloon, providing reliable inflation status information without adding complex monitoring infrastructure
3Measurement precision
If complex indicator systems are used to provide detailed pressure readings, then measurement precision improves, but ease of operation deteriorates due to interpretation difficulty
Solution Approach 1:
The patent uses simple color changes or visibility transitions in the indicator that are intuitively understood by users. Rather than displaying numerical pressure values or complex graphical readings that require interpretation, the indicator provides clear binary or discrete visual signals (e.g., color change from clear to colored, or appearance/disappearance of a visible portion) that are immediately recognizable and eliminate interpretation difficulties
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 solution provides a clear and easy-to-interpret visual signal for pressure changes in the balloon, ensuring accurate inflation status without the need for complex indicator systems, reducing the risk of tissue damage and improving user understanding of balloon inflation states.
Implementation Method 1
a pre-biased indicator that provides a discrete visual signal that a volume of a balloon is different from a predetermined fill volume
Implementation Method 2
an inflatable balloon having a predetermined fill volume for holding at least a portion of the assembly in a body lumen
Data Source
AI summary
A catheter assembly incorporating a pre-biased indicator, the assembly includes a catheter having a proximal end, a distal end, and catheter walls defining a catheter lumen. The assembly further includes a base located at the proximal end of the catheter, the base defining an opening to the catheter lumen, the base having a first end and a second end. An inflatable balloon having a predetermined fill volume is located at a distal end of the catheter. An inflation valve is located on the base; the inflation valve is in fluid communication with the balloon through an inflation lumen defined by the catheter walls. The pre-biased indicator located on the base in fluid communication with the balloon is configured to provide a discrete visual signal that the pressure of a fluid in the balloon is different from a predetermined level of pressure or the volume of the balloon is different from the predetermined fill volume.