Catheter Midstream Sample Collection Device

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Solution Overview

Problem

Collecting uncontaminated urine samples, especially from female patients, is challenging due to vaginal secretions and bacterial contamination, which often renders the samples unusable for medical tests, particularly in pediatric, elderly, and obese populations.

Innovation Solution

A catheter device with a fluid conduit, waste channel, and flow control valve allows for the separation and discard of the initial contaminated flow, redirecting the subsequent urine into a sterile collection receptacle, thereby minimizing contamination and ensuring a clean sample collection.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If urine is collected via catheterization, then sample collection is achieved, but contamination with vaginal secretions and bacteria occurs

Engineering Contradiction:
Improvesample cleanlinessVSAvoidcontamination
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The catheter is divided into separate functional segments: a first lumen for initial flow and a second lumen for sample collection. This segmentation allows the initial contaminated flow to be separated from the subsequent clean urine sample, resolving the contradiction between achieving sample collection and preventing contamination.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The initial flow of urine containing vaginal secretions and bacteria is extracted and discarded through the first lumen before the clean sample is collected through the second lumen. This extraction of the harmful initial flow eliminates contamination while maintaining reliable sample collection.

Inventive Principle:
Principle #2Taking out (Extraction)

2Object-affected harmful factors

If washing/sterilization is performed on the urethral opening, then contamination is minimized, but the initial stream remains contaminated

Engineering Contradiction:
ImprovecontaminationVSAvoidsample cleanliness
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The device performs preliminary action by directing the initial flow through a first lumen that is separate from the collection path. This preliminary flow carries away contaminants that remain despite washing, ensuring that the subsequent sample collected through the second lumen is clean and reliable.

Inventive Principle:
Principle #10Preliminary action

3Reliability

If the initial flow is discarded, then contamination is removed, but sample collection volume is reduced

Engineering Contradiction:
Improvesample cleanlinessVSAvoidsample volume
Core Design Contradiction:
ReliabilityVSQuantity of substance

Solution Approach 1:

The catheter's dual-lumen structure segments the urine flow into an initial discard portion and a collection portion. This segmentation enables complete separation of contaminants from the sample, ensuring adequate clean sample volume is collected in the second lumen while the first lumen handles only the initial flow.

Inventive Principle:
Principle #1Segmentation

Data Source

PatentUS11717643B2Device for midstream sample collection from a catheterized subject and method and systems for use thereof
Publication Date: 2023.08.08 HUNT STEPHEN J
  • US11717643B2 patent drawing
  • US11717643B2 patent drawing
  • US11717643B2 patent drawing

AI summary

Disclosed herein are devices and methods for collecting samples of bodily fluid that may be substantially free of contamination, even where an initial amount of contamination may be present in a collection device, such as a urethral catheter. In the disclosed device and methods, the sample may be collected mid-stream, after an initial amount of fluid has flushed away the initial contamination. The disclosed devices may include a diverter device comprising a fluid control valve that may manually be moved between a first position and a second position that, respectively, direct fluid to two different channels and/or receptacles.