Soluble Membrane Urine Collection Device for Sterile Midstream Sampling

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Solution Overview

Problem

Current methods for collecting midstream urine samples are inconvenient, prone to contamination, and require significant mobility and dexterity, often resulting in non-sterile specimens that may be contaminated with initial urine bacteria, making them less than ideal for accurate testing.

Innovation Solution

A device with a channel and opening covered by a soluble or temperature-sensitive membrane that dissolves after initial urine flow, allowing a collector to receive a urine sample from subsequent flows, which can include a urinary catheter or test device with integrated test pads for on-site analysis.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a soluble membrane is used to cover the opening in the channel, then the device can automatically distinguish between initial urine flow and subsequent midstream flow, but the device complexity increases due to the additional membrane component

Engineering Contradiction:
Improvespecimen sterilityVSAvoiddevice structure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The soluble membrane changes its physical state from intact to dissolved based on contact with urine. This parameter change allows the membrane to automatically distinguish between initial urine flow (where it remains intact) and subsequent midstream flow (where it dissolves), enabling reliable specimen collection without complex mechanical components.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The soluble membrane is a single-use, disposable component that is discarded after serving its purpose. This approach simplifies the overall device by using a low-cost, easily replaced membrane rather than a complex, reusable mechanism, thereby reducing device complexity while maintaining reliability.

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

2Device complexity

If the member is a non-soluble membrane fixed by adhesive, then the device structure is simpler, but the adhesive may contaminate the urine sample or fail to release properly

Engineering Contradiction:
Improvedevice structureVSAvoidadhesive contamination
Core Design Contradiction:
Device complexityVSObject-affected harmful factors

Solution Approach 1:

The adhesive is designed as a temporary, disposable bonding agent that is discarded along with the membrane after use. This eliminates the risk of adhesive contamination in the urine sample, as the adhesive does not remain in the collection system. The membrane is replaced with a new unit for each patient, ensuring no cross-contamination.

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

Solution Approach 2:

The adhesive is extracted from the final product that contacts the urine. By using a soluble membrane that dissolves completely in urine, the adhesive function is separated from the urine-contacting component. The membrane itself serves as the barrier and is discarded after use, removing any adhesive contamination risk.

Inventive Principle:
Principle #2Taking out (Extraction)

3Stability of the object's composition

If the member is a non-soluble membrane with temperature-sensitive adhesive, then the membrane remains stable structurally, but the adhesive effectiveness changes with temperature which may affect reliability

Engineering Contradiction:
Improvemembrane stabilityVSAvoidadhesive effectiveness
Core Design Contradiction:
Stability of the object's compositionVSReliability

Solution Approach 1:

Instead of relying on temperature-sensitive adhesive, the invention uses a soluble membrane that changes its state based on urine contact. This parameter change approach is more reliable than temperature-dependent adhesion, as urine composition and flow characteristics are more consistent indicators of midstream flow than temperature variations.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The membrane is designed as a disposable component that is replaced after each use. This eliminates the need for complex, reusable adhesive mechanisms that could fail due to temperature sensitivity. The simple, single-use soluble membrane provides consistent performance without relying on temperature-dependent adhesive properties.

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

4Object-affected harmful factors

If the member is initially impermeable but becomes permeable in contact with urine, then the device can prevent initial contamination, but the timing of permeability change must be precise to avoid capturing initial flow

Engineering Contradiction:
Improvebacterial contaminationVSAvoidpermeability timing
Core Design Contradiction:
Object-affected harmful factorsVSManufacturing precision

Solution Approach 1:

The soluble membrane undergoes a parameter change from impermeable to permeable based on urine contact. This chemical dissolution process provides a reliable timing mechanism that is less sensitive to precise manufacturing tolerances than physical permeability changes. The membrane dissolves completely in urine, ensuring all subsequent flow is captured while the initial flow is blocked.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The membrane is designed as a disposable component with a simple dissolution mechanism. This approach eliminates the need for complex, reusable permeability control systems that would require high manufacturing precision. The single-use soluble membrane provides sufficient timing precision through its complete dissolution in urine, capturing midstream flow reliably.

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

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

Enables the collection of a sterile urine sample that avoids initial bacteria contamination, facilitating convenient and accurate testing without the need for laboratory analysis, improving specimen quality and reducing procedural errors.

Implementation Method 1

the member may be a soluble membrane which dissolves after urine has flowed through the channel for a period of time

Methodology Applied
Scientific EffectDissolution: Solvation

Implementation Method 2

a non-soluble membrane which is initially impermeable but increases in permeablity when in contact with liquid (urine)

Methodology Applied
Scientific EffectPermeability increase: Permeation

Data Source

PatentEP2107889B1A device and method for the collection of a urine sample
Publication Date: 2012.08.01 HOLLISTER INCORPORAED
  • EP2107889B1 patent drawingFigure 1~2
  • EP2107889B1 patent drawingFigure 3~4D
  • EP2107889B1 patent drawingFigure 5A~5B

AI summary

A device and method for collection of a urine sample is disclosed which comprises a channel, an opening in the channel, and a collector associated with the opening. The channel is formed so that urine can flow through it from a first end to a second end thereof. The opening is provided in the channel at a point between the first and the second ends thereof. The collector is associated with the opening in the channel to be able to receive urine therein. In one embodiment, a member can cover the opening to permit urine to pass through it after contact with urine. Specifically, the member may dissolve or otherwise permit urine to pass through the opening after a period of time to test a urine sample which is not from the initial flow of urine to avoid bacteria contamination.