Retention Balloon Over-Inflation Prevention Apparatus
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Solution Overview
Problem
Current medical devices with inflatable retention balloons, such as those in fecal management systems and endotracheal tubes, face challenges in preventing over inflation, which can lead to excessive pressure on surrounding tissues, and existing solutions like pressure relief valves or electronic fluid measurement systems are complex, costly, or ineffective.
Innovation Solution
The development of an apparatus that monitors fluid pressure or volume in the balloon, using a pressure-responsive deformable member or volume monitoring mechanisms to prevent over inflation by controlling fluid flow through a valve system, ensuring the balloon does not exceed a predetermined pressure or volume, thereby preventing tissue damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If a pressure relief valve is used to prevent over inflation, then tissue damage is prevented, but the device complexity increases
Solution Approach 1:
The retention balloon itself serves the dual function of both retaining the catheter and preventing over-inflation through its burst pressure characteristics. The balloon is designed with a specific burst pressure that automatically limits the maximum pressure applied to surrounding tissues, eliminating the need for separate pressure relief valves or complex electronic monitoring systems.
Solution Approach 2:
The balloon material and construction are selected to provide specific pressure-volume characteristics. By changing the physical parameters of the balloon (material strength, thickness, geometry), the system achieves automatic pressure limitation without additional mechanical or electronic components.
2Measurement precision
If electronic fluid measurement systems are used to monitor balloon inflation, then inflation accuracy is improved, but the device complexity and cost increase
Solution Approach 1:
The balloon's physical properties (burst pressure, elastic limits) automatically provide measurement and limitation of inflation volume. The system uses the balloon itself as the measuring device through its inherent pressure-volume relationship, eliminating electronic sensors, processors, and power sources.
Solution Approach 2:
The balloon is designed as a single-use or limited-use component with built-in safety characteristics. Rather than using expensive reusable electronic monitoring systems, the patent employs a disposable balloon with integrated safety features that cannot be reset or reused after deployment.
3Reliability
If the retention balloon is over inflated to ensure secure retention, then retention reliability is improved, but tissue damage risk increases
Solution Approach 1:
The balloon is engineered with specific pressure-volume characteristics that provide adequate retention force while automatically limiting maximum pressure. The material selection and geometric design ensure the balloon achieves sufficient expansion for secure catheter fixation without exceeding safe pressure thresholds for surrounding tissues.
Solution Approach 2:
The balloon provides inherent feedback through its pressure-volume relationship. As inflation proceeds, the increasing back-pressure automatically limits further expansion, providing natural feedback that prevents over-inflation while maintaining adequate retention force.
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
This solution effectively prevents over inflation of the retention balloon, reducing the risk of tissue damage by accurately limiting fluid intake based on pressure or volume, providing a simpler, less costly, and more reliable method compared to existing technologies.
Implementation Method 1
a pressure-responsive deformable member or volume monitoring mechanisms to prevent over inflation by controlling fluid flow through a valve system
Data Source
Figure 1
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Figure 4
AI summary
The body has a fluid inlet port for receiving pressurized fluid and a fluid outlet port connected to the retention balloon. A first passage connects the fluid inlet port and the fluid outlet port, A second passage in the body is connected to the balloon fluid return path and is at the pressure of the retention balloon. A. valve prevents fluid flow through the first passage when actuated. The valve includes a pressure-responsive member movable to a position to obstruct fluid flow in response to fluid pressure in the second passage exceeding the predetermined level. Flexible means such as a membrane defines a normally open portion of the first fluid passage, which is closed by the moveable means bearing on the membrane when pressure exceeding the predetermined level actuates the valve.