ARFI Imaging Catheter for Pulmonary Vein Lesion Durability
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Solution Overview
Problem
Current pulmonary vein isolation (PVI) procedures face challenges in assessing the durability of ablation lesions, leading to uncertainty and high rates of PV reconnection, as existing methods cannot distinguish between durable tissue destruction and incomplete ablation.
Innovation Solution
An imaging catheter system with an inflatable balloon for anchoring and an impulse generator to conduct mechanical impulses, combined with acoustic radiation force impulse (ARFI) imaging, which provides high-resolution displacement information to assess tissue elasticity and lesion durability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If electrical isolation measurements are used to confirm PVI, then acute conduction block can be demonstrated, but the durability of the isolation lesion cannot be assessed
Solution Approach 1:
The patent replaces electrical measurement methods with mechanical impulse delivery and acoustic imaging to assess tissue properties. The impulse generator delivers mechanical impulses through the balloon, and acoustic radiation force impulse imaging detects tissue displacement, providing information about tissue elasticity and durability that electrical measurements cannot provide.
Solution Approach 2:
The patent changes the measurement parameter from electrical conduction block to mechanical tissue displacement and elasticity. By using acoustic radiation force impulse imaging to measure tissue displacement in response to mechanical impulses, the system provides information about tissue destruction completeness and lesion durability.
2Measurement precision
If high-density voltage mapping is used to confirm PVI, then conduction block can be demonstrated, but distinction between durable destruction and incomplete ablation remains impossible
Solution Approach 1:
The patent replaces complex electrical voltage mapping systems with a mechanical impulse delivery system combined with acoustic imaging. The impulse generator and acoustic imaging system provide tissue durability assessment without requiring complex high-density voltage mapping infrastructure.
Solution Approach 2:
The patent introduces acoustic waves as an intermediary to assess tissue properties. The mechanical impulses generate acoustic radiation force that displaces tissue, and the resulting displacement is detected and used to infer tissue durability and ablation completeness.
3Reliability
If repeat ablation procedures are performed due to uncertainty, then PV reconnection can be treated, but patient exposure to additional procedures and risks increases
Solution Approach 1:
The patent provides real-time feedback on lesion durability and ablation completeness during the procedure. The acoustic radiation force impulse imaging system continuously monitors tissue displacement and elasticity, allowing the operator to assess whether the ablation lesion is durable and complete, reducing uncertainty about long-term success.
Solution Approach 2:
The patent performs lesion durability assessment during the initial ablation procedure rather than waiting for follow-up. By using mechanical impulse delivery and acoustic imaging to evaluate tissue destruction completeness in real-time, the system allows preliminary assessment of whether repeat procedures will be needed.
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
The system effectively evaluates the completeness and durability of ablation lesions, improving long-term success rates of PVI procedures by directly visualizing irreversible thermo-coagulation necrosis and distinguishing between complete and incomplete ablation lines.
Implementation Method 1
acoustic radiation force impulse (ARFI) imaging, which provides high-resolution displacement information to assess tissue elasticity and lesion durability
Data Source
AI summary
Aspects of the present disclosure describe systems, methods, and structures for pulmonary vein isolation lesion evaluation that advantageously determine lesion durability.