Catheter Placement Verification Using Segmented Flashback Channels

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Solution Overview

Problem

Existing catheter placement verification methods, such as visualizing blood flashback through a transparent catheter, are prone to inaccuracies due to variations in introducer needle gauge sizes, leading to failed catheter insertions.

Innovation Solution

A catheter system with a transparent gap between the introducer needle and catheter lumen, combined with bio-impedance sensors and absorbent materials, provides clear blood flow visualization and electronic confirmation of catheter and introducer needle placement within the vein.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If blood flashback visualization is used to confirm catheter placement, then placement verification is achieved, but measurement precision deteriorates due to variations in introducer needle gauge sizes causing confusion between needle and catheter entry

Engineering Contradiction:
Improvecatheter placement verification accuracyVSAvoidinformation about which component entered the vein
Core Design Contradiction:
Measurement precisionVSLoss of information

Solution Approach 1:

The patent divides the single visualization space into two separate channels: one dedicated to visualizing introducer needle entry (with flashback) and another for visualizing catheter entry (without flashback). This segmentation allows independent observation of each component's placement status, eliminating the confusion caused by overlapping visual signals in the traditional single-channel approach.

Inventive Principle:
Principle #1Segmentation

2Reliability

If traditional flashback visualization is used, then device complexity is minimized, but reliability deteriorates due to inaccurate placement confirmation

Engineering Contradiction:
Improveplacement verification reliabilityVSAvoidcatheter system structure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent introduces a spatial dimension by creating separate visualization channels at different locations and orientations. The first channel visualizes needle entry at one location while the second channel visualizes catheter entry at another location, adding spatial differentiation to the visualization process. This dimensional separation enhances reliability by providing distinct visual confirmation for each component without requiring complex electronic or mechanical systems.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

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

Enhances the accuracy of catheter placement verification by reducing confusion between introducer needle and catheter entry into the vein, facilitating precise insertion and reducing failed placements.

Implementation Method 1

the gap may be in fluid communication with the holes such that in response to the holes being inserted into a vein, blood may flow through the holes and into the gap

Methodology Applied
Scientific EffectFluid flow:

Implementation Method 2

combined with bio-impedance sensors and absorbent materials, provides clear blood flow visualization and electronic confirmation of catheter and introducer needle placement within the vein

Methodology Applied
Scientific EffectBio-impedance: Electrical Impedance Tomography

Implementation Method 3

combined with bio-impedance sensors and absorbent materials, provides clear blood flow visualization

Methodology Applied
Scientific EffectAbsorption: Absorption (physical)

Data Source

PatentUS12434037B2Confirmation of catheter placement within a vein
Publication Date: 2025.10.07 BECTON DICKINSON & CO
  • US12434037B2 patent drawing
  • US12434037B2 patent drawing
  • US12434037B2 patent drawing

AI summary

A catheter system may include a catheter adapter, which may include a distal end and a proximal end. The catheter system may include a catheter, which may include a distal end, a proximal end, a catheter lumen extending through the distal end of the catheter and the proximal end of the catheter, and an inner surface forming the catheter lumen. The catheter may extend distally from the distal end of the catheter adapter. The distal end of the catheter may include one or more holes. The distal end of the catheter may include one or more channels. The holes and/or the channels may facilitate visualization of blood flashback indicating the catheter is disposed within a vein of a patient.