Stoma Length Indicator Assembly for Catheter Positioning
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing catheter devices for enteral feeding face challenges such as initial placement discomfort due to aggressive pressure application, and changes in stoma tract length over time due to weight gain or inflammation, leading to discomfort, pain, and potential leakage or device movement.
Innovation Solution
An indicator assembly with a first retainer deployed within the body and a second retainer outside the body, featuring an external indicator that signals changes in stoma length through visual or tactile cues, ensuring proper positioning and preventing device displacement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If aggressive pressure is applied when seating the retainer to ensure secure placement, then the retainer is firmly positioned, but the stoma tract is squeezed causing discomfort and pain for the patient
Solution Approach 1:
The patent applies preliminary action by providing an indicator assembly that signals the correct seating position of the retainer before full insertion is completed. The indicator (such as a visual flag or color change element) becomes visible when the retainer reaches the proper position, allowing the physician to stop insertion before applying excessive pressure. This prevents the harmful squeezing of the stoma tract while ensuring the retainer is securely positioned at the correct depth.
2Ease of manufacture
If the device structure is made simple without indicators, then manufacturing is easier and cost is reduced, but the physician cannot determine proper axial positioning of the retention system
Solution Approach 1:
The patent employs color changes as a simple yet effective indicator mechanism. The indicator assembly includes a color-changing element (such as a colored band, flag, or window revealing a colored background) that becomes visible when the retainer reaches the correct axial position. This color indication provides clear visual feedback to the physician without requiring complex mechanical or electronic systems, thus maintaining ease of manufacture while achieving precise positioning measurement.
Solution Approach 2:
The indicator assembly serves as an intermediary element between the retainer and the physician. It translates the internal positioning state of the retainer (which is otherwise invisible) into an external visible signal. The indicator is attached to or associated with the retainer mechanism and provides real-time feedback during insertion, enabling the physician to accurately determine when proper positioning has been achieved without needing to rely on estimation or complex measurement tools.
3Device complexity
If no indicator system is provided, then the device structure remains simple, but changes in stoma length over time cannot be detected, leading to discomfort, leakage or device movement
Solution Approach 1:
The patent implements feedback by providing an indicator system that continuously monitors and signals the axial position of the retainer relative to the stoma tract. When tissue growth, weight gain, or inflammation causes the stoma tract to lengthen, the indicator becomes visible (or changes position/color), providing immediate feedback that the retainer has shifted from its optimal position. This enables timely adjustment or repositioning to maintain device reliability and prevent leakage or discomfort.
Data Source
Figure 1
Figure 2
Figure 3~4B
AI summary
An indicator assembly for use with a non-vascular catheter device The indicator assembly includes: a first retainer secured to a catheter tube, the first retainer being an indwelling retainer which is deployed within a non-vascular lumen or cavity of the body; a second retainer secured to the catheter tube, the second retainer deployed outside the human body; and an indicator located outside the body on the catheter tube between the first retainer and the second retainer. The first retainer and the second retainer are configured to maintain substantially the same position with respect to each other on the tube and the indicator is configured to signal a change in position with respect to either the first or the second retainer, thereby indicating a change in the length of a stoma.