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 catheter placement and functionality, which can result in delayed diagnosis and increased healthcare costs.

Innovation Solution

The use of two physiologic sources, such as an in-line pressure sensor and a finger pulse sensor, to perform correlation analysis of beats-per-minute and waveform cross-correlation, verifying the cardiac pulsewave and confirming proper needle or catheter placement and patency.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Device complexity

If a single pressure sensor is used to detect cardiac pulsewave, then the device complexity is low, but the measurement precision deteriorates due to false positives from non-cardiac pulsations

Engineering Contradiction:
Improvedevice complexityVSAvoidmeasurement precision
Core Design Contradiction:
Device complexityVSMeasurement precision

Solution Approach 1:

The patent combines two independent pressure sensors (first pressure sensor in fluid communication with the needle/catheter, second pressure sensor as a reference) to detect cardiac pulsewaves. By merging the measurements from both sensors and analyzing their correlation, the system achieves higher measurement precision in differentiating true cardiac pulsations from non-cardiac pressure changes, while maintaining relatively simple device architecture.

Inventive Principle:
Principle #5Merging (Combining)

2Measurement precision

If correlation analysis with multiple sensors is implemented, then the measurement precision improves, but the device complexity increases

Engineering Contradiction:
Improvemeasurement precisionVSAvoiddevice complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent introduces a processor as an intermediary that automatically performs correlation analysis on the signals from multiple pressure sensors. This intermediary component handles the complex computational tasks of comparing waveforms, calculating correlation coefficients, and determining cardiac pulse presence, thereby achieving high measurement precision without requiring complex manual intervention or overly complicated device architecture.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Device complexity

If manual observation of therapeutic drug response is used to evaluate catheter function, then the device complexity remains low, but the loss of time increases significantly

Engineering Contradiction:
Improvedevice complexityVSAvoidloss of time
Core Design Contradiction:
Device complexityVSLoss of time

Solution Approach 1:

The patent performs preliminary detection of cardiac pulsewaves through pressure sensor correlation analysis before administering therapeutic drugs. By establishing catheter functionality and proper placement through automated pulsewave verification in advance, the system eliminates the need for time-consuming post-administration observation periods (typically 20-30 minutes), thereby significantly reducing loss of time while maintaining simple device complexity.

Inventive Principle:
Principle #10Preliminary action

4Productivity

If automated electromechanical motor systems are used for fluid delivery, then the productivity improves, but the device complexity and cost increase

Engineering Contradiction:
ImproveproductivityVSAvoiddevice complexity
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The patent employs pressure sensors and automated correlation analysis to enable self-verification of catheter placement and functionality. The system automatically detects cardiac pulsewaves, confirms proper catheter positioning, and verifies patency without requiring complex electromechanical motor systems for fluid delivery. This self-service approach maintains productivity by ensuring accurate catheter function assessment while avoiding the added complexity and cost of automated infusion pumps.

Inventive Principle:
Principle #25Self-service

Data Source

PatentUS12096957B2Device and method for needle/catheter location utilizing correlation analysis
Publication Date: 2024.09.24 MILESTONE SCIENTIFIC INC
  • US12096957B2 patent drawing
  • US12096957B2 patent drawing
  • US12096957B2 patent drawing

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.