Waste Management Appliance with Balloon Pressure Relief for Insertion
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Solution Overview
Problem
Existing balloon catheters face issues such as the need for a balance between softness and rigidity for insertion, potential for bowel perforation due to rigid tools, risk of over-inflation causing tissue damage, and complexity in construction and use, along with increased costs for multi-part systems.
Innovation Solution
A waste management appliance with a tubular body and an inflatable balloon, featuring a cowl that forms finger pockets for easy insertion and prevents over-inflation by incorporating a pressure relief valve and a lubricious coating, reducing the risk of bowel perforation and tissue damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If the catheter is made soft and pliable to enhance subject comfort, then subject comfort is improved, but the device becomes difficult to insert into the subject
Solution Approach 1:
The catheter is divided into distinct segments with different properties: a soft, compliant distal end for subject comfort and a more rigid proximal end and insertion tool for ease of insertion. This segmentation allows each part to fulfill its specific function without compromise
Solution Approach 2:
A separate insertion tool acts as an intermediary device that provides the necessary rigidity for insertion while the actual catheter remains soft. The insertion tool facilitates insertion of the soft catheter without requiring the catheter itself to be rigid
2Ease of operation
If a rigid insertion tool is used to facilitate insertion of the soft catheter, then ease of insertion is improved, but the risk of bowel perforation increases
Solution Approach 1:
The insertion tool and catheter are merged into a single integrated unit with the tool formed as part of the catheter assembly. This integration ensures the tool is designed specifically for its purpose and eliminates the need for separate rigid instruments that could cause perforation
Solution Approach 2:
The insertion tool is designed with specific dimensional parameters and material properties that allow it to provide sufficient rigidity for insertion while maintaining safety. The tool's geometry and material selection are optimized to minimize tissue damage risk
3Ease of operation
If a separate insertion tool is used, then ease of insertion is improved, but the system complexity and cost increase
Solution Approach 1:
The insertion tool and catheter are combined into a single integrated device rather than separate components. This merging reduces system complexity, eliminates the need for multiple parts, and simplifies both manufacturing and clinical use while maintaining the ease of insertion benefit
4Reliability
If the balloon is over-inflated to ensure retention, then retention is improved, but tissue damage occurs
Solution Approach 1:
The system incorporates feedback mechanisms that provide real-time information about balloon inflation status. This feedback allows the operator to monitor inflation levels and stop before over-inflation occurs, ensuring retention while preventing tissue damage
Solution Approach 2:
The catheter design includes preliminary features such as positioning pockets and specific balloon geometry that ensure proper placement and retention before inflation is complete. This preliminary action reduces the need for high inflation pressures that could cause tissue damage
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 appliance ensures easy insertion, prevents over-inflation, and maintains patient comfort while minimizing the risk of complications and costs, all without requiring additional lumens or complex mechanisms.
Implementation Method 1
incorporating a pressure relief valve and a lubricious coating, reducing the risk of bowel perforation and tissue damage
Data Source
Figure 1~2
Figure 3~5
Figure 6
AI summary
A waste management appliance comprising: a tubular body having proximal and distal ends; a balloon coupled to the tubular body in the vicinity of the proximal end thereof; an inflation lumen opening at a proximal end to the interior of said balloon and extending distally from the balloon towards the distal end of the tubular body, and a valve assembly (1) fluidly coupled to the inflation lumen, the valve assembly comprising (1) a valve body having first and second valve chambers (3, 5) in fluid communication with said inflation lumen, a coupling for connecting the lumen to a source of fluid being provided in said first chamber (3), and a pressure relief valve (11) being provided in said second chamber (5); the arrangement being such that the insertion of fluid into said lumen via said coupling from a source of fluid inflates said balloon until the balloon and lumen contain a predetermined quantity of fluid, whereupon continued insertion of fluid causes said pressure relief valve (11) to operate and fluid to leak from the lumen via said valve (11) instead of further inflating said balloon.