ECG-Based Catheter Positioning Adapter

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Solution Overview

Problem

Current methods for positioning endovascular devices, such as central venous catheters, lack precision and rely heavily on chest X-rays, which are not always accurate for discriminating between specific locations in the cardiovascular system, and remote monitoring of heart conditions is limited by complex signal acquisition and communication challenges.

Innovation Solution

A computer-based method using electrocardiogram (ECG) signals to accurately position endovascular devices by processing ECG waveforms to calculate P-wave amplitudes and spectral powers, determining the device's location based on these calculations, and displaying the information to the user, thereby reducing the need for chest X-rays and enhancing remote monitoring capabilities.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If chest X-ray is used for confirming catheter tip location, then location confirmation is achieved, but radiation exposure increases and real-time guidance is not available

Engineering Contradiction:
Improvecatheter tip location confirmationVSAvoidradiation exposure
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The patent replaces the mechanical/radiological system (chest X-ray) with an electrical signal-based system (ECG guidance). The ECG guidance system uses electrical potentials generated by the heart to determine catheter tip location, eliminating the need for ionizing radiation while providing real-time feedback during the procedure.

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

Solution Approach 2:

The patent introduces ECG signals as an intermediary to indirectly determine catheter tip location. Instead of directly imaging the catheter tip with X-rays, the system uses the heart's electrical activity as a mediator to infer the catheter's position based on characteristic ECG waveform changes at different anatomical locations.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Speed

If electromagnetic guiding systems are used, then real-time guidance is provided, but accuracy in discriminating specific locations is limited

Engineering Contradiction:
Improvereal-time guidanceVSAvoidlocation discrimination accuracy
Core Design Contradiction:
SpeedVSMeasurement precision

Solution Approach 1:

The patent utilizes changes in ECG waveform parameters (amplitude, morphology, electrical potentials) that occur as the catheter moves through different anatomical locations. By monitoring these parameter changes in real-time, the system achieves both rapid guidance and precise location discrimination, overcoming the limitations of electromagnetic systems that rely on fixed reference points.

Inventive Principle:
Principle #35Parameter changes

3Adaptability or versatility

If ECG-based systems are used for remote monitoring, then monitoring capability is enhanced, but signal acquisition complexity increases

Engineering Contradiction:
Improveremote monitoring capabilityVSAvoidsignal acquisition system
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The patent makes the ECG system multi-functional by using the same ECG guidance technology for both real-time catheter positioning during the procedure and for post-procedure remote monitoring. This universal application reduces overall system complexity compared to having separate specialized systems for each function.

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 improves the accuracy of endovascular device placement and reduces the reliance on chest X-rays, providing real-time guidance and enabling more effective remote monitoring of heart conditions by utilizing ECG signals to determine precise locations within the cardiovascular system.

Implementation Method 1

The electrical conduction system of the heart creates specific electrical signals, electrical energy distributions and behaviors thereof which are indicative of specific locations in the thoracic cavity and/or of specific heart functions or conditions.

Methodology Applied
Scientific EffectElectrical conduction: Conduction (electrical)

Implementation Method 2

The heart's electrical activity produces currents that radiate through the surrounding tissue to the skin. When electrodes are attached to the skin, they sense these electrical currents and transmit them the electrocardiograph.

Methodology Applied
Scientific EffectElectrical radiation: Electric Field

Data Source

PatentEP3542713A1Adapter for a catheter tip positioning device
Publication Date: 2019.09.25 BARD ACCESS SYSTEMS INC
  • EP3542713A1 patent drawingFigure 1
  • EP3542713A1 patent drawingFigure 2A~2C
  • EP3542713A1 patent drawingFigure 3

AI summary

An adaptor for endovascular electrocardiography, comprising: a member having a first end, a second end, and an inner lumen, the first end connectable to a luer of a catheter and the second end connectable to a syringe, such that fluid from the syringe is flushed into the catheter through the inner lumen; and a metal insert, in particular a metal ring, disposed along the inner lumen of the member and located inside the member, the metal ring connecting through a sealed electrical connection to an outer side of the member. An assembly for endovascular electrocardiography, comprising: the adaptor; and a connector separate from the member of the adaptor coupled to the metal ring.