Lesion Analysis Processor for RF Ablation Feedback

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Solution Overview

Problem

Current RF ablation catheters lack effective methods for real-time monitoring of lesion formation in tissue, particularly in cardiac tissue, which can lead to uncertainties in lesion depth and transmurality during procedures.

Innovation Solution

A system incorporating a lesion analysis processor that receives A-line scan echograms to determine lesion progress through changes in brightness, tissue elasticity, acoustic reflector movement, and resonant microbubble distribution, providing feedback on lesion formation using ultrasound transducers integrated within the catheter tip.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If RF ablation is performed without real-time lesion monitoring, then the ablation procedure can be performed quickly, but the lesion depth and transmurality cannot be accurately determined

Engineering Contradiction:
Improvelesion depth measurementVSAvoidprocedure time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The system incorporates real-time feedback by continuously monitoring echograms during RF ablation and comparing them to reference echograms. The lesion analysis processor provides immediate feedback on lesion depth and formation progress, allowing operators to adjust ablation parameters dynamically without extending overall procedure time significantly.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The patent replaces mechanical measurement methods (such as physical probes or post-procedure imaging) with ultrasound-based acoustic monitoring. The echogram analysis system uses acoustic wave reflection patterns to non-invasively measure lesion depth in real-time, substituting complex mechanical measurement systems with a more integrated acoustic field-based approach.

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

2Measurement precision

If multiple monitoring parameters are analyzed to improve lesion accuracy, then lesion formation can be precisely monitored, but the system complexity increases

Engineering Contradiction:
Improvelesion formation monitoring accuracyVSAvoidmonitoring system complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The echogram-based monitoring system serves multiple functions simultaneously: it measures lesion depth, detects lesion formation progress, identifies steam pop events, and provides feedback on ablation effectiveness. This multi-functional approach consolidates what would otherwise require separate monitoring devices into a single integrated system.

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

Solution Approach 2:

The system creates simplified representations (copies) of complex tissue changes by analyzing echogram brightness patterns and acoustic reflector movements. Instead of directly measuring multiple physical parameters, the system uses echogram image analysis to infer lesion characteristics, reducing the complexity of direct multi-parameter measurement while maintaining monitoring accuracy.

Inventive Principle:
Principle #26Copying

3Measurement precision

If real-time echogram analysis is performed to monitor lesion depth, then accurate lesion control is achieved, but processing requirements and computational load increase

Engineering Contradiction:
Improvelesion depth determinationVSAvoidprocessing energy consumption
Core Design Contradiction:
Measurement precisionVSUse of energy by moving object

Solution Approach 1:

The system extracts only the most critical features from echograms for analysis, such as brightness changes in specific regions and movements of acoustic reflectors. By focusing computational resources on these key indicators rather than processing entire echogram images in full detail, the system reduces computational load and energy consumption while maintaining accurate lesion depth determination.

Inventive Principle:
Principle #2Taking out (Extraction)

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

Enables real-time monitoring and feedback on lesion formation, allowing for precise control of ablation depth and preventing complications such as steam pops, thereby improving the accuracy and safety of RF ablation procedures.

Implementation Method 1

an acoustic sensor (e.g., a pulse-echo transducer; a photoacoustic transducer) that can be used to monitor the formation of a lesion

Methodology Applied
Scientific EffectUltrasound: Ultrasound

Implementation Method 2

a pulse-echo transducer

Methodology Applied
Scientific EffectEcho: Echo

Implementation Method 3

tissue elasticity as evidenced by changes in acoustic reflector movement between echograms

Methodology Applied
Scientific EffectAcoustic reflection: Reflection

Implementation Method 4

tissue shrinkage as evidenced by acoustic reflector movement between echograms

Methodology Applied
Scientific EffectAcoustic reflection: Reflection

Implementation Method 5

changes in resonant microbubble distribution from echogram to echogram

Methodology Applied
Scientific EffectResonance: Resonance

Data Source

PatentEP3226773B1Systems for lesion formation feedback
Publication Date: 2023.10.25 ST JUDE MEDICAL CARDILOGY DIV INC
  • EP3226773B1 patent drawingFigure 1
  • EP3226773B1 patent drawingFigure 2
  • EP3226773B1 patent drawingFigure 3

AI summary

Apparatuses, systems, and methods of monitoring lesion formation using one-dimensional echograms are disclosed. In certain aspects, lesion formation progress is monitored using the intensity of reflectors in successive echograms during ablation. In another aspect, lesion formation progress is monitored based upon actual or apparent movement of acoustic reflectors before and after ablation. In still another aspect, the presence or absence of resonant microbubbles known to populate forming lesions are used to provide feedback on lesion formation. A lesion analysis processor can be programmed to determine lesion formation progress using any of the foregoing approaches, either alone or in various combinations.