Needle Assembly Diagnostic Sampling Port Segmentation

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Solution Overview

Problem

Conventional IV catheters pose risks of fluid spillage and inadvertent needle sticks when accessing blood samples from the flashback chamber, especially with non-removable flash plugs, which require cumbersome external devices and increase contamination risks.

Innovation Solution

A safety needle assembly with a diagnostic sampling port and a gas permeable flash plug allows direct access to the flashback chamber, reducing spillage risk and incorporating a self-sealing mechanism and heparin coating for fluid integrity, or a hinged end cap for safe removal of the flash plug, and color-changing substances for visual patient condition indicators.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a non-removable flash plug is used to seal the flashback chamber, then fluid containment is improved, but access to fluid samples becomes difficult and requires cumbersome external devices

Engineering Contradiction:
Improvefluid containmentVSAvoidaccess to fluid samples
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The flash plug is segmented into a removable portion and a retained portion. The removable portion can be detached to allow fluid sampling, while the retained portion remains to maintain the seal. This segmentation resolves the contradiction by enabling both fluid containment (through the retained portion) and sample access (through the removable portion).

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The removable portion of the flash plug is extracted from the flashback chamber to enable fluid sampling. This extraction allows clinicians to access blood samples without removing the entire flash plug, maintaining the seal while enabling sampling. The extracted portion can be discarded after use.

Inventive Principle:
Principle #2Taking out (Extraction)

2Ease of operation

If the flash plug is removed to access blood samples, then sample collection is enabled, but fluid spillage risk increases

Engineering Contradiction:
Improvesample collectionVSAvoidfluid spillage
Core Design Contradiction:
Ease of operationVSObject-generated harmful factors

Solution Approach 1:

By segmenting the flash plug into removable and retained portions, the system enables sample collection through the removable portion while the retained portion continues to seal the flashback chamber. This prevents fluid spillage that would occur if the entire plug were removed.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The removable portion of the flash plug acts as an intermediary element that can be detached for sampling while the retained portion maintains the seal. This intermediary structure allows controlled access to fluids without compromising the overall containment system.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Reliability

If external devices are used to access blood through a non-removable flash plug, then fluid containment is maintained, but device complexity and contamination risk increase

Engineering Contradiction:
Improvefluid containmentVSAvoidaccess mechanism
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The flash plug is designed with a removable portion that can be easily detached by hand, eliminating the need for complex external devices. This segmentation provides a simple, integrated solution that reduces device complexity while maintaining fluid containment through the retained portion.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The removable portion of the flash plug is designed to be easily removed by the clinician without requiring additional tools or devices. This self-service design simplifies the access mechanism while the retained portion continues to maintain fluid containment.

Inventive Principle:
Principle #25Self-service

4Ease of operation

If the flash plug is completely removed for sampling, then access is maximized, but needle stick risk increases

Engineering Contradiction:
Improveaccess to flashback chamberVSAvoidneedle stick risk
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The flash plug is segmented so that only the removable portion is detached for sampling, while the retained portion remains in place to cover and protect the needle. This segmentation enables access to the flashback chamber for sampling while maintaining protection against needle stick injuries.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Only the necessary portion of the flash plug (the removable portion) is extracted for sampling purposes. The retained portion remains to continue sealing the chamber and, more importantly, to protect the needle from inadvertent contact. This selective extraction minimizes needle stick risk while enabling sampling.

Inventive Principle:
Principle #2Taking out (Extraction)

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 enables safe and efficient access to fluid samples within the flashback chamber, minimizing spillage and needle stick risks while providing visual indicators of patient conditions, thus enhancing clinical safety and accuracy.

Implementation Method 1

The cavity defining wall further includes structure defining a diagnostic sampling port configured to enable selective access to the cavity

Methodology Applied
Scientific EffectGas permeability: Permeation

Implementation Method 2

incorporating a self-sealing mechanism and heparin coating for fluid integrity

Methodology Applied
Scientific EffectSelf-sealing:

Implementation Method 3

incorporating a self-sealing mechanism and heparin coating for fluid integrity

Methodology Applied
Scientific EffectHeparin anticoagulation:

Implementation Method 4

color-changing substances for visual patient condition indicators

Methodology Applied
Scientific EffectColor change indication: Thermochromism

Data Source

PatentUS10028691B2Needle assembly with diagnostic analysis provisions
Publication Date: 2018.07.24 ICU MEDICAL INC
  • US10028691B2 patent drawing
  • US10028691B2 patent drawing
  • US10028691B2 patent drawing

AI summary

A needle assembly. The needle assembly enabling the analysis of fluid trapped in a flashback chamber after an insertion needle has been inserted into a patient's vein.