Self-Intermittent Catheter Extension with Infection Detection

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Solution Overview

Problem

Individuals with neurogenic bladders, due to spinal cord injuries or other conditions, often experience delayed detection of urinary tract infections (UTIs) leading to severe complications, including sepsis and death, as they lack sensation to timely treat infections.

Innovation Solution

A self-intermittent urinary catheter extension system with an integrated indicator assembly that includes a wicking member and indicators for detecting Nitrite and Leukocyte presence in urine, allowing for early visual indication of infections through color change, thereby facilitating timely intervention.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If individuals with neurogenic bladders use self-intermittent urinary catheters without infection detection, then the catheter system remains simple and inexpensive, but UTIs are not detected timely leading to severe complications including sepsis and death

Engineering Contradiction:
Improveinfection detection capabilityVSAvoidcatheter system complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent applies color change indicators that react to specific substances (nitrite, leukocytes, blood) in urine. When infection markers are detected, the indicator changes color to provide visual alert. This resolves the contradiction by adding reliable infection detection through simple visual color changes without requiring complex electronic or mechanical systems.

Inventive Principle:
Principle #32Color changes

Solution Approach 2:

The patent introduces an intermediary indicator assembly that mediates between the urine flow and the user. The indicator assembly contains wicking material that draws urine to the reaction zone where chemical indicators detect infection markers. This intermediary system provides reliable detection while maintaining simplicity by using passive chemical reactions rather than active sensing mechanisms.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If a catheter system includes integrated infection detection indicators, then timely detection of UTIs is enabled, but the manufacturing complexity and cost increase

Engineering Contradiction:
Improveinfection detection accuracyVSAvoidcatheter manufacturing simplicity
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The patent segments the catheter system into distinct functional components: the catheter tube, the indicator assembly, and the collection bag. The indicator assembly is a separate module that can be manufactured independently and then attached to the catheter system. This segmentation resolves the manufacturing complexity by allowing each component to be produced using specialized processes while maintaining overall system simplicity through modular assembly.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent employs disposable indicator assemblies containing chemical indicators that are inexpensive to manufacture. These indicators use simple chemical reactions with nitrite, leukocytes, or blood in urine to produce color changes. The disposable nature of these indicators keeps per-unit costs low while providing reliable detection, resolving the contradiction between detection accuracy and manufacturing cost.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

3Loss of information

If the catheter extension uses clear sealing members to allow visual inspection of indicators, then infection detection visibility is improved, but the sealing effectiveness may be compromised

Engineering Contradiction:
Improveindicator visibilityVSAvoidsealing effectiveness
Core Design Contradiction:
Loss of informationVSReliability

Solution Approach 1:

The patent applies local quality by making the sealing member transparent or translucent only in the specific region where the indicator assembly is located, while other sealing portions can be opaque. This allows visual inspection of the indicator color changes through the sealing member without compromising the overall sealing effectiveness, as the transparency is localized to where visual detection is needed rather than affecting the entire sealing structure.

Inventive Principle:
Principle #3Local quality

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 system enables early detection of UTIs, reducing the incidence of severe complications and hospital stays by providing a visual indication of infection presence, thus enabling prompt medical attention.

Implementation Method 1

a wicking member and an indicator. The wicking member is configured to wick urine from the catheter to the indicator

Methodology Applied
Scientific EffectCapillary action: Capillary Action

Data Source

PatentUS12076500B2Self-intermittent urinary catheter extension with infection detection, a catheter assembly having an extension with infection detection and a catheter assembly having infection detection
Publication Date: 2024.09.03 ADVOCATH LLC
  • US12076500B2 patent drawing
  • US12076500B2 patent drawing
  • US12076500B2 patent drawing

AI summary

An extension assembly for a catheter comprises an extension tube, an extension connector, and an indicator assembly. The extension tube has a proximal end and a distal end. The extension tube further has an inner bore and an opening placing an interior of the extension tube in fluid communication with an exterior of the extension tube. The extension connector is coupled to the proximal end of the extension tube. The indicator assembly is comprised of a sealing member, a wicking member, and an indicator. The sealing member including a first side and a second side. The wicking member includes a wicking tab to be disposed within the opening of the extension tube. The indicator is in fluid communication with the wicking member. The sealing member is at least partially clear to allow visual inspection of the indicator once the indicator assembly is coupled to the extension tube.