ICG Dye Fluorescence for Lesion Visualization During Ablation

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Solution Overview

Problem

Current ablation procedures for cardiac arrhythmias, particularly atrial fibrillation, face challenges in visually distinguishing treated tissue from de novo tissue due to deep penetration of ablation energy and limited visibility through endoscopes, leading to potential undertreatment or overtreatment and the need for repeated surgeries.

Innovation Solution

The use of an indocyanine green (ICG) dye composition, delivered to the surgical site, which fluoresces under specific energy emission, allowing an imaging system to differentiate between ablated and non-ablated tissue through fluorescence imaging, enabling real-time visualization and correction of lesion formation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If ablation energy is applied deeply into tissue to create lesions, then treatment effectiveness is improved, but visual distinction between treated and untreated tissue deteriorates

Engineering Contradiction:
Improvetreatment effectivenessVSAvoidvisual distinction of tissue
Core Design Contradiction:
ReliabilityVSDifficulty of detecting and measuring

Solution Approach 1:

An optical indicator (fluorescent dye) is introduced as an intermediary substance that accumulates in untreated tissue and emits fluorescence when excited by light. This mediator provides visual contrast between treated and untreated tissue without interfering with the deep-penetrating ablation energy, thereby resolving the contradiction between effective treatment and visual detection.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent utilizes fluorescence emission (color change) as a visual indicator to distinguish treated from untreated tissue. The optical indicator fluoresces under excitation light, creating a visible color difference that allows real-time monitoring of ablation progress while maintaining deep tissue penetration capability.

Inventive Principle:
Principle #32Color changes

2Reliability

If ablation energy is applied to create continuous scar tissue, then electrical isolation is achieved, but risk of overtreatment and structural damage increases

Engineering Contradiction:
Improveelectrical isolationVSAvoidstructural damage
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The fluorescent optical indicator provides real-time visual feedback during the ablation procedure. By monitoring the fluorescence signal, operators can assess treatment progress and stop ablation when sufficient electrical isolation is achieved, preventing overtreatment and associated structural damage while ensuring complete electrical isolation.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The patent enables precise control of ablation energy application by using fluorescence as a guide. Instead of applying excessive energy to ensure complete isolation, the fluorescent indicator allows stopping at the optimal point where sufficient isolation is achieved, reducing harmful effects while maintaining treatment effectiveness.

Inventive Principle:
Principle #16Partial or excessive action

3Ease of operation

If percutaneous ablation devices are used, then invasiveness is reduced, but ability to visually monitor lesion formation deteriorates

Engineering Contradiction:
Improveminimally invasive approachVSAvoidlesion visualization
Core Design Contradiction:
Ease of operationVSDifficulty of detecting and measuring

Solution Approach 1:

The fluorescent optical indicator serves as a mediator that enables visual monitoring of lesion formation in percutaneous procedures. The indicator accumulates in tissue and fluoresces under excitation light, providing real-time visual feedback that compensates for the limited direct visualization inherent in minimally invasive approaches.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent utilizes fluorescence-induced color changes to enable visual monitoring of ablation progress in percutaneous procedures. The optical indicator's fluorescent emission creates visible contrast between treated and untreated tissue, allowing operators to monitor lesion formation despite the minimally invasive nature of the procedure.

Inventive Principle:
Principle #32Color changes

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 immediate and accurate visualization of lesions relative to de novo tissue, allowing surgeons to detect deficiencies and take corrective action, thereby ensuring complete and continuous ablation formation, reducing the need for repeat procedures.

Implementation Method 1

A second energy emitter is provided for applying energy of a type and in an amount sufficient to cause the ICG composition to fluoresce

Methodology Applied
Scientific EffectFluorescence: Fluorescence

Data Source

PatentUS11246476B2Method for visualizing tissue with an ICG dye composition during ablation procedures
Publication Date: 2022.02.15 CARDIOFOCUS INC
  • US11246476B2 patent drawing
  • US11246476B2 patent drawing
  • US11246476B2 patent drawing

AI summary

A system is provided for identifying the sufficiency of lesions formed during a tissue ablation procedure. The system and method include administering an ICG composition to the patient and forming one or more lesions at a surgical site. The method further includes applying energy of a type and in an amount sufficient to cause ICG in the patient to fluoresce. An image of the tissue and lesion at the surgical site is obtained while the ICG fluoresces. The lesion is distinguished from surrounding de novo tissue based on areas of fluorescence to allow a user to evaluate the quality of the lesion.