Needle Catheter Placement Verification via Correlation Analysis

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Solution Overview

Problem

Current devices lack the ability to accurately differentiate between cardiac and non-cardiac pulsations detected by needles or catheters, leading to false positives and difficulties in determining proper placement and functionality, which can result in delayed diagnosis and increased healthcare costs.

Innovation Solution

The use of two physiologic sources, such as a cardiac pulsewave detected by an in-line pressure sensor and a heartbeat detected by a finger pulse sensor, for correlation analysis to verify the presence of a cardiac pulsewave, thereby confirming correct needle or catheter placement and patency.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If a single pressure sensor is used to detect pulsations in the needle or catheter, then the device can detect pressure changes, but it cannot differentiate between cardiac and non-cardiac pulsations leading to false positives

Engineering Contradiction:
Improveaccuracy of cardiac pulse detectionVSAvoidfalse positive rate
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

The patent combines multiple independent sensors (needle pressure sensor, catheter pressure sensor, and finger pulse sensor) to detect cardiovascular signals. By merging the detection capabilities of these sensors, the system can cross-validate signals and differentiate true cardiac pulsations from non-cardiac pressure changes, thereby reducing false positives while maintaining detection accuracy.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The system uses feedback from multiple sensor sources to verify detected pulsations. The finger pulse sensor provides reference cardiac signal feedback that is compared against signals from the needle and catheter pressure sensors. This feedback mechanism allows the system to confirm whether detected pressure changes represent true cardiac activity or artifacts, improving both measurement precision and reliability.

Inventive Principle:
Principle #23Feedback

2Loss of time

If no verification system is used, then the device is simple and inexpensive, but it cannot rule out false positives and requires 20-30 minutes for catheter function evaluation

Engineering Contradiction:
Improvecatheter evaluation timeVSAvoidnumber of sensors and analysis system
Core Design Contradiction:
Loss of timeVSDevice complexity

Solution Approach 1:

The system performs preliminary verification of catheter placement and function by continuously monitoring and analyzing pressure signals from multiple sensors. The correlation analysis between different sensor signals is performed in real-time to confirm proper catheter positioning before medication administration, eliminating the need for lengthy 20-30 minute observation periods while maintaining reasonable system complexity.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent replaces the traditional mechanical/wait-based evaluation method with an electronic signal analysis system. Instead of waiting 20-30 minutes for therapeutic drug response observation, the system uses electronic correlation analysis of pressure waveforms from multiple sensors to rapidly verify catheter function, significantly reducing evaluation time while adding moderate complexity through electronic monitoring.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

3Reliability

If correlation analysis with multiple sensors is implemented, then false positives are reduced and placement accuracy is confirmed, but the device complexity and cost increase

Engineering Contradiction:
Improveconfirmation of true cardiac pulseVSAvoidmultiple sensors and correlation system
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The system uses a multi-functional approach where the finger pulse sensor serves dual purposes: it provides reference cardiac signal for correlation analysis and also functions as an independent verification source. The pressure sensors in the needle and catheter serve both therapeutic delivery functions and diagnostic verification functions, reducing the need for additional dedicated verification components and thereby limiting the increase in device complexity.

Inventive Principle:
Principle #6Universality (Multi-functionality)

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

This method allows for real-time, confident assessment of needle or catheter placement, reducing false positives and enabling manual medication delivery with precise control, thus preventing catheter dislodgement and improving patient safety and treatment efficiency.

Implementation Method 1

detecting a pressure change in a needle or catheter that is indicative of a cardiac pulse

Methodology Applied
Scientific EffectPressure wave transmission:

Implementation Method 2

detecting a cardiovascular response from the patient with a finger pulse sensor or other sensor known to detect a heartbeat

Methodology Applied
Scientific EffectCardiovascular response detection:

Data Source

PatentEP4138968B1Device for needle/catheter location utilizing correlation analysis
Publication Date: 2024.10.23 MILESTONE SCIENTIFIC INC
  • EP4138968B1 patent drawingFigure 1
  • EP4138968B1 patent drawingFigure 2
  • EP4138968B1 patent drawingFigure 3

AI summary

An apparatus and method to enable clinicians to verify needle or catheter location within an anatomic site by relying upon combined sensing of two signals, such as a pressure signal and a heart rate pulse signal, in which the detection of a correlation between both signals is identified to confirm location of the needle or catheter.