Fluid-Filled Seal for Ostomy Appliances
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Solution Overview
Problem
Existing ostomy appliances face challenges in maintaining a consistent contact pressure between the membrane seal and the stoma, which can lead to leakage or reduced blood perfusion due to dynamic movements of the stoma during wear, as changes in stoma position affect inflation pressure and volume.
Innovation Solution
A controlled evacuation ostomy appliance with a fluid-filled seal featuring a resilient device within the chamber that dynamically manages chamber volume and pressure, using a port system to control fluid admission and discharge, allowing for expansion and damping actions to compensate for stoma movement and maintain optimal contact pressure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the inflation chamber volume is increased to accommodate stoma movement, then the seal reliability is improved, but the contact pressure decreases leading to leakage risk
Solution Approach 1:
The patent applies dynamics by making the inflation chamber volume variable rather than fixed. The chamber can dynamically expand or contract in response to stoma movement, allowing the system to adapt to changing conditions while maintaining both adequate contact pressure and seal reliability throughout the wear period.
Solution Approach 2:
The patent changes the parameter of chamber volume from a static value to a dynamic variable. By allowing the inflation fluid volume to change in response to stoma position changes, the system maintains optimal contact pressure despite stoma movement, thereby preventing leakage while ensuring adequate perfusion.
2Reliability
If the contact pressure is increased to prevent leakage, then the seal reliability is improved, but the blood perfusion in stoma tissue is reduced
Solution Approach 1:
The system dynamically adjusts chamber volume to maintain contact pressure within an optimal range. When stoma moves inward increasing chamber volume, the system can add inflation fluid to maintain pressure. When stoma moves outward decreasing chamber volume, the system can allow fluid discharge to reduce pressure, thereby preventing both leakage and tissue damage.
Solution Approach 2:
The patent implements a feedback mechanism where the system responds to changes in stoma position and chamber volume. The check valve and port system provide feedback control, allowing the chamber to self-regulate its volume and pressure in response to stoma movement, maintaining contact pressure within safe and effective limits.
3Stress or pressure
If the check valve prevents discharge of inflation fluid, then the contact pressure is maintained, but the inflation pressure becomes unpredictable under dynamic stoma movement
Solution Approach 1:
The patent segments the fluid control system into two distinct pathways: a check valve for fluid admission that prevents backward flow, and a separate port system for controlled fluid discharge. This segmentation allows independent control of inflation and deflation processes, enabling the system to adapt pressure in response to stoma movement while maintaining reliable sealing.
Solution Approach 2:
The port system acts as an intermediary between the inflation chamber and the external environment. It mediates the discharge of inflation fluid in a controlled manner, allowing pressure reduction when needed while preventing uncontrolled loss of inflation pressure, thus bridging the gap between maintaining pressure and adapting to dynamic conditions.
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 maintains a consistent contact pressure, reducing the risk of leakage while ensuring adequate blood perfusion by dynamically adjusting to stoma movements, thereby improving the reliability and comfort of the ostomy appliance.
Implementation Method 1
a resilient device disposed within the fluid chamber... configured to urge the membrane in a direction (i) for forming a seal in use and/or (ii) for expanding the chamber
Implementation Method 2
The membrane seal conforms to and bears against the stoma with a distributed contact force that is dependent on the pressure of inflation fluid in the chamber
Implementation Method 3
one or more ports communicating with the chamber... configured to control the admission and/or discharge of fluid with respect to the chamber
Implementation Method 4
The resilient device can apply a force to expand the chamber to compensate for stoma movement... providing a damping action
Data Source
Figure 1~2
Figure 1A
Figure 3~5
AI summary
A medical device such as a controlled discharge ostomy appliance comprises a fluid filled seal for sealing around a body orifice (stoma). The fluid filled seal comprises a fluid chamber including a fluid impermeable membrane that forms a movable wall of the fluid chamber, one or more ports communicating with the chamber; and resilient foam disposed within the fluid chamber. The foam tends to expand the chamber to seal against the body. The port controls the inlet and exhaust of fluid from the chamber, in response to movement of the body away from, or towards, the seal.