Pressure-Deflatable Foley Catheter Balloon with Safety Valve
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Solution Overview
Problem
Balloon-based catheters face safety issues during operation and installation within the human body, including pressure-related injuries, urethral trauma, and difficulties in deflation, which can lead to complications such as bleeding, scarring, and catheter retention due to inadequate pressure relief mechanisms.
Innovation Solution
A catheter design featuring a primary balloon with a restraining mechanism that maintains fluid communication within predefined pressure thresholds, using a stretchable band or weak area to control pressure, and a flow controller to automatically vent excess pressure, ensuring safe operation and reusability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a balloon-based catheter is inflated to retain it inside a body part, then the catheter can perform its function, but excess pressure can cause patient discomfort, damage to the bladder or urinary tract
Solution Approach 1:
The balloon is divided into two separate chambers: a first chamber for inflation to achieve catheter retention, and a second chamber that acts as a pressure relief mechanism. This segmentation allows the catheter to maintain its retention function while providing a dedicated pathway for excess pressure release, preventing pressure-related injuries to the bladder and urinary tract.
Solution Approach 2:
A valve mechanism serves as an intermediary between the two balloon chambers and the external environment. This valve controls fluid communication between the chambers and automatically opens to release excess pressure from the first chamber to the second chamber or to the environment, thereby mediating the pressure management while maintaining catheter retention.
2Reliability
If the balloon is inflated before complete insertion into the urinary bladder, then the balloon can be secured, but this can cause urethral injury, bleeding, and scarring
Solution Approach 1:
The catheter is designed with a deflation channel that is prepared in advance but remains closed during insertion. This preliminary setup allows the balloon to be inflated only after complete insertion into the bladder, as the deflation channel will automatically activate if excessive pressure is detected during insertion, preventing urethral trauma while maintaining the ability to secure the balloon when properly positioned.
Solution Approach 2:
The potential harmful effect of premature inflation is converted into a safety feature. The pressure relief mechanism, which could be seen as a potential leak or failure, is actually designed to prevent harm by releasing pressure if the catheter is inflated too early in the urethra. This transforms what could be a design flaw into a protective mechanism that prevents urethral injury, bleeding, and scarring.
3Object-affected harmful factors
If the catheter is designed with pressure relief mechanisms, then patient safety is improved, but the device complexity increases
Solution Approach 1:
The pressure relief mechanism is merged with the balloon structure itself by creating a second chamber within the same balloon assembly. This integration eliminates the need for separate external pressure relief devices, reducing overall system complexity while still providing effective pressure management to prevent patient injuries.
Solution Approach 2:
The catheter employs passive, automatic pressure relief mechanisms that do not require external monitoring or control systems. The valve and chamber design automatically respond to pressure changes, with the second chamber or valve opening to release excess pressure when needed. This self-regulating system reduces device complexity by eliminating the need for electronic sensors, pumps, or external control mechanisms.
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 manages pressure within safe limits, reducing the risk of injury and trauma, allowing for safe and efficient operation of the catheter while maintaining reusability and minimizing the need for continuous monitoring.
Implementation Method 1
a stretchable band which covers a part of the primary balloon dividing the primary balloon into the first part and the second part
Implementation Method 2
a flow controller which is adapted to open the fluid communication channel between the first part of the primary balloon and the external environment when a pressure inside the first part of the primary balloon surpasses a second predefined threshold
Data Source
AI summary
A catheter (1) is disclosed which has a primary balloon (2) to be inflated or deflated, a pumping means (3) for pumping a working fluid into and out of the primary balloon (2) to inflate or deflate it, and a restraining mechanism (4) to keep a first part (5) of the primary balloon (2) or an opening (7) of the primary balloon (2) in a restrained position until a pressure inside the primary balloon (2) is within a predefined threshold and in an expanded position when the pressure inside the primary balloon (2) surpasses the predefined threshold and until the pressure inside the primary balloon (2) gets below the predefined threshold. This helps in retaining the working fluid inside the primary balloon (2) until the pressure is within the threshold, and to move it out of the balloon when it is beyond the threshold.