RF Ablation Catheter with Optical Tissue Evaluation

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Solution Overview

Problem

RF ablation for treating atrial fibrillation faces challenges in achieving consistent results due to variability in electrical power delivery, tissue properties, and blood flow, leading to incomplete ablation and long intervention times, with current tools unable to accurately identify incomplete necrosis or ensure lesion continuity.

Innovation Solution

Integration of low coherence interferometry (LCI) with RF ablation catheters to provide real-time monitoring of lesion transmurality, continuity, and energy delivery, using optical elements to transmit and receive radiation for depth-resolved data, which updates thermal property models and aids in automatic control of the ablation process.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If point-to-point RF ablation is performed to create continuous lines around anatomical structures, then electrical isolation effect is achieved, but intervention time becomes excessively long

Engineering Contradiction:
Improveelectrical isolation effectVSAvoidintervention time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent implements real-time optical monitoring using low coherence interferometry to provide feedback on tissue denaturation, lesion continuity, and transmurality during ablation. This allows the clinician to adjust the ablation process dynamically, ensuring complete electrical isolation while reducing the number of individual lesions needed, thereby shortening intervention time.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The system performs preliminary assessment of tissue properties and ablation parameters before and during the procedure. By pre-planning the ablation pattern based on anatomical mapping and continuously monitoring tissue response, the system optimizes the ablation process to achieve electrical isolation more efficiently without requiring excessive individual lesions.

Inventive Principle:
Principle #10Preliminary action

2Reliability

If multiple individual lesions are concatenated to ensure continuous ablation lines, then electrical isolation is achieved, but lesion continuity cannot be properly verified

Engineering Contradiction:
Improveelectrical isolationVSAvoidlesion continuity verification
Core Design Contradiction:
ReliabilityVSMeasurement precision

Solution Approach 1:

The patent replaces mechanical/visual inspection methods with optical coherence tomography imaging to verify lesion continuity. The optical imaging system provides non-contact, real-time visualization of the ablation lesions, allowing precise verification of continuity and completeness without relying on manual inspection or fluoroscopy.

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

Solution Approach 2:

The patent introduces optical imaging as an intermediary tool between the ablation process and the clinician's assessment. The optical system acts as a mediator that translates tissue changes into visual information, enabling accurate verification of lesion continuity and quality without direct mechanical measurement or reliance on indirect indicators.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Ease of operation

If fluoroscopy is used to support catheter ablation, then procedural guidance is provided, but radiation dose to clinician and patient increases significantly

Engineering Contradiction:
Improveprocedural guidanceVSAvoidradiation dose
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The patent replaces fluoroscopy (ionizing radiation-based imaging) with optical coherence tomography (non-ionizing optical imaging) for procedural guidance and monitoring. The optical imaging system provides real-time visualization of tissue structure and ablation lesions without exposing the patient and clinician to ionizing radiation, thereby eliminating the harmful radiation dose while maintaining procedural guidance capability.

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

4Reliability

If RF ablation parameters are adjusted to account for tissue variability, then ablation effectiveness improves, but procedure complexity and clinician expertise requirements increase

Engineering Contradiction:
Improveablation effectivenessVSAvoidprocedure complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent implements a self-monitoring ablation system where the optical imaging system automatically tracks tissue changes, lesion formation, and energy delivery in real-time. The system provides self-assessment of ablation quality and completeness, reducing the need for complex manual adjustments and high-level clinician expertise while maintaining high ablation effectiveness through automated feedback and monitoring.

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

Enhances the consistency and effectiveness of RF ablation by providing immediate feedback on tissue denaturation and energy distribution, reducing intervention times and improving lesion continuity, while minimizing radiation exposure for both clinicians and patients.

Implementation Method 1

The multiplexer generates the one or more beams of exposure radiation from the source beam of radiation

Methodology Applied
Scientific EffectLight modulation:

Implementation Method 2

receive one or more beams of scattered radiation that have been reflected or scattered from the sample

Methodology Applied
Scientific EffectLight scattering: Scattering

Implementation Method 3

receive one or more beams of scattered radiation that have been reflected or scattered from the sample

Methodology Applied
Scientific EffectReflection: Reflection

Implementation Method 4

a detector that generates depth-resolved optical data associated with the one or more beams of scattered radiation

Methodology Applied
Scientific EffectPhotoelectric detection: Photoelectric Effect

Implementation Method 5

The application of alternating current with an oscillating frequency above several hundreds of kHz avoids the stimulation of excitable tissue while delivering heat by means of the Joule's effect

Methodology Applied
Scientific EffectJoule heating: Joule Heating

Implementation Method 6

The increase in tissue temperature produces denaturation of the biological molecules, including proteins such as collagen

Methodology Applied
Scientific EffectProtein denaturation:

Data Source

PatentUS20210077181A1Radiofrequency ablation catheter with optical tissue evaluation
Publication Date: 2021.03.18 MEDLUMICS
  • US20210077181A1 patent drawing
  • US20210077181A1 patent drawing
  • US20210077181A1 patent drawing

AI summary

Systems and methods for performing RF ablation while monitoring the procedure using low coherence interferometry (LCI) data are described. A catheter includes a distal section, a proximal section, a multiplexer, and a sheath coupled between the distal section and the proximal section. The distal section includes one or more electrodes configured to apply RF energy to a portion of a sample in contact with the electrode. The distal section also includes a plurality of optical elements configured to transmit one or more beams of exposure radiation away from the distal section of the catheter. The proximal section includes an optical source configured to generate a source beam of radiation and a detector configured to generate depth-resolved optical data. The multiplexer is configured to generate the one or more beams of exposure radiation from the source beam of radiation.