Fistula Management Device With Inflatable Balloon Cuffs
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Solution Overview
Problem
Current methods for managing enterocutaneous and enteroatmospheric fistulas are ineffective in preventing enteric contents from leaking, leading to fluid and nutritional losses and skin breakdown, as existing appliances tend to leak, especially with high output.
Innovation Solution
A fistula management device with inflatable balloon cuffs at each end, which creates a fluid seal against the bowel walls when inflated, diverting enteric contents through a tubular body to prevent leakage through the fistula opening.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If ostomy or wound management appliances are used to control fistula output, then some level of containment is achieved, but leakage occurs especially when output is high
Solution Approach 1:
The patent applies pneumatic pressure through inflatable balloon cuffs that create a seal against the bowel wall. By inflating the cuffs with fluid or gas, a reliable seal is formed that prevents enteric contents from leaking, directly resolving the containment reliability issue while preventing substance loss.
Solution Approach 2:
The patent changes the physical state and pressure parameters by inflating the balloon cuffs from a deflated to an inflated state. This parameter change allows the cuffs to expand and create an effective seal against the bowel, transforming the device from a non-functional to a highly effective containment system.
2Ease of operation
If negative pressure or vacuum assisted healing techniques are used to direct enteric contents away, then some directional control is achieved, but leakage prevention remains insufficient
Solution Approach 1:
The patent replaces negative pressure techniques with positive pneumatic pressure applied through inflated balloon cuffs. This creates a reliable mechanical seal that physically blocks enteric contents from leaking, providing both ease of operation and high reliability in leakage prevention.
3Reliability
If a seal is created against bowel walls to prevent leakage, then leakage prevention is improved, but device complexity increases
Solution Approach 1:
The patent divides the sealing function into multiple segments by using separate inflatable balloon cuffs at different locations along the device. Each cuff can be independently inflated to create seals at specific points, providing reliable leakage prevention while maintaining manageable device complexity through modular functionality.
4Reliability
If balloon cuffs are inflated to create a fluid seal, then enteric contents are diverted effectively, but risk of bowel wall damage increases
Solution Approach 1:
The patent carefully controls the pressure parameters of the inflated balloon cuffs to achieve effective sealing and content diversion while maintaining pressure levels that prevent bowel wall damage. The parameter change from deflated to inflated state is controlled to balance effectiveness with safety.
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
Effectively prevents enteric contents from leaking out of the bowel by creating a seal and diverting them through the device, reducing fluid and nutritional losses and promoting fistula closure.
Implementation Method 1
A fluid seal between each of the balloon cuffs and inner walls of the bowel is created in a second step by inflating each of the balloon cuffs
Data Source
AI summary
A fistula management device for preventing enteric contents from leaking out of a bowel via a fistula opening in the bowel. The device comprises a tubular body that defines a main fluidic passageway extending from a first axial end to a second axial end of the tubular body. Inflatable cuffs are located at each of the first and second axial ends of the tubular body for creating a fluid seal between the first and second axial ends of the tubular body and inner walls of a bowel.