Inflatable Device Pressure Relief Valve for Balloon Over-Inflation
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Solution Overview
Problem
Existing indwelling medical devices, particularly fecal management systems, face challenges in controlling and maintaining proper pressure within inflatable portions like retention balloons to prevent over-inflation, which can cause bruising, ulceration, and infection, while ensuring a small footprint and flexibility to accommodate varying patient anatomies.
Innovation Solution
Incorporation of pressure relief valves, such as umbrella, spring-loaded ball, and spring-loaded poppet valves, within the outlet lumen of retention balloons, along with a fill indicator, to prevent over-inflation by allowing fluid release when pressure exceeds predetermined limits, while maintaining a small footprint and accommodating patient-specific pressure ranges.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a pressure relief valve is incorporated into the outlet lumen to prevent over-inflation, then patient safety is improved by preventing tissue damage, but the device complexity increases due to additional valve components
Solution Approach 1:
The pressure relief valve is nested within the outlet lumen structure, with the valve seat and disc integrated into the existing catheter wall. The valve components are contained within the lumen space, utilizing the existing structural envelope rather than adding external components, thereby minimizing increased device complexity while maintaining safety functionality.
Solution Approach 2:
The pressure relief valve operates automatically based on pressure differential alone, without requiring external control mechanisms. The valve disc responds directly to pressure changes across the lumen wall, opening when internal pressure exceeds external pressure by a threshold amount, and closing automatically when pressure equalizes. This self-regulating mechanism prevents over-inflation without adding complex control systems.
2Adaptability or versatility
If the valve height is reduced to maintain a small footprint, then device flexibility and adaptability are improved, but the valve cracking pressure control becomes more difficult to achieve
Solution Approach 1:
The valve seat is positioned at a specific location within the outlet lumen where the wall thickness provides the necessary cracking pressure control. The local structural characteristics of the lumen wall at the valve seat location determine the pressure threshold, allowing precise control of cracking pressure through localized design features rather than requiring the entire valve assembly to be tall or complex.
Solution Approach 2:
The cracking pressure is controlled by changing the physical parameters of the valve components, specifically the stiffness and dimensions of the valve disc and the geometry of the valve seat. By adjusting these parameters, the desired cracking pressure can be achieved within a compact valve height, balancing flexibility with pressure control precision.
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 effectively prevents over-inflation, ensuring safe operation by providing visual and audible notifications, and allowing for patient-specific pressure adjustments, thereby reducing tissue damage and infection risks while maintaining device functionality.
Implementation Method 1
a pressure relief valve configured to open when a pressure within the inflatable portion exceeds a predetermined pressure
Data Source
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AI summary
Valves and valve systems are provided that are useful for integration with inflatable indwelling medical devices to prevent over-inflation of retention balloon.