Endovascular ECG Energy Mapping for Catheter Navigation

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Solution Overview

Problem

Current methods for guiding endovascular devices, such as central venous catheters, rely on chest X-rays, which lack precision for discriminating between specific locations in the cardiovascular system, and electromagnetic systems, which do not utilize anatomical information effectively, while ECG-based systems offer improved accuracy but are limited by the complexity of acquiring heart activity signals and communication challenges in remote monitoring.

Innovation Solution

The use of simultaneous skin surface and endovascular ECG signals to enhance the navigation and placement of endovascular devices by synchronizing and analyzing these signals, allowing for real-time monitoring and precise location determination within the cardiovascular system, utilizing algorithms to interpret changes in ECG waveforms and energy patterns for accurate catheter tip placement.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If chest X-ray is used for catheter tip location confirmation, then the current golden standard is provided, but the precision for discriminating between specific locations is insufficient

Engineering Contradiction:
Improvecatheter tip location precisionVSAvoidimaging system complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent replaces the mechanical/imaging-based chest X-ray system with an electrical field-based ECG monitoring system. By measuring electrical potentials and analyzing ECG waveforms, the system determines catheter tip location without requiring complex imaging equipment, thus improving precision while reducing device complexity

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

Solution Approach 2:

The patent introduces ECG waveforms and electrical potential measurements as intermediary indicators to infer catheter tip location. Instead of directly visualizing the catheter position through X-ray, the system uses electrical signals from the heart as a mediator to indirectly but more precisely determine location

Inventive Principle:
Principle #24Intermediary (Mediator)

2Productivity

If electromagnetic guiding system is used, then real-time guidance is provided, but the anatomical information is not effectively utilized

Engineering Contradiction:
Improvecatheter placement efficiencyVSAvoidanatomical information utilization
Core Design Contradiction:
ProductivityVSLoss of information

Solution Approach 1:

The patent implements feedback by continuously monitoring ECG waveforms and comparing them against known anatomical electrical signatures. As the catheter moves through different cardiac chambers and vessels, the changing ECG patterns provide real-time feedback about location, effectively utilizing anatomical information to guide placement

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The patent monitors changes in electrical parameters (ECG waveform morphology, amplitude, frequency) that occur as the catheter tip moves through different anatomical locations. These parameter changes reflect the underlying anatomy and provide guidance information without losing anatomical context

Inventive Principle:
Principle #35Parameter changes

3Measurement precision

If ECG-based system is used for remote monitoring, then improved accuracy is achieved, but the signal acquisition complexity increases

Engineering Contradiction:
Improvelocation determination accuracyVSAvoidsignal acquisition system complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent makes the ECG monitoring system multi-functional by using the same electrical potential measurements for both traditional cardiac monitoring and catheter location determination. This universal approach improves location accuracy without requiring separate complex acquisition systems

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

Solution Approach 2:

The patent combines catheter location determination with standard ECG monitoring into a single integrated system. By merging these functions, the system achieves improved location accuracy while avoiding the complexity of separate dedicated location-finding equipment

Inventive Principle:
Principle #5Merging (Combining)

4Object-affected harmful factors

If ECG-based system is used, then chest X-ray confirmation can be eliminated, but the ease of operation is reduced due to signal interpretation complexity

Engineering Contradiction:
Improveradiation exposureVSAvoidsignal interpretation difficulty
Core Design Contradiction:
Object-affected harmful factorsVSEase of operation

Solution Approach 1:

The patent implements automated algorithms that independently analyze ECG waveforms and determine catheter tip location without requiring manual interpretation. The system self-processed the complex signal analysis, eliminating radiation exposure while maintaining ease of operation through automation

Inventive Principle:
Principle #25Self-service

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 approach improves the ease of use and accuracy of catheter navigation, reduces the need for X-rays, and enables effective remote monitoring of heart conditions by providing reliable and precise location information for endovascular device placement, enhancing patient safety and procedural success rates.

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)

Data Source

PatentEP2618727B1Apparatus and method for catheter navigation using endovascular energy mapping
Publication Date: 2022.06.22 CR BARD INC
  • EP2618727B1 patent drawingFigure 1A
  • EP2618727B1 patent drawingFigure 1B
  • EP2618727B1 patent drawingFigure 2

AI summary

Devices and methods for obtaining and using endovascular electrograms in a number of clinical applications and settings are disclosed. In one embodiment, a method is disclosed for locating an indwelling medical device within a vasculature of a patient. The method comprises identifying an endovascular ECG waveform complex from an endovascular ECG signal associated with the indwelling medical device, then calculating an absolute value of the energy of the endovascular ECG waveform complex over a predetermined segment thereof. A position of the medical device within the vasculature is then determined by observation of the absolute value of the energy of the predetermined segment of the endovascular ECG waveform complex.