Closed-Loop Ablation Control for Adaptive Lesion Formation
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Solution Overview
Problem
Existing ablation therapies, such as radiofrequency ablation (RFA) and pulsed field ablation (PFA), lack the ability to adapt to real-world circumstances, delivering fixed treatments without considering patient anatomy or tissue response, which can lead to suboptimal lesion formation.
Innovation Solution
A closed-loop ablation system with a processor that receives tissue properties and ablation waveform parameters to compute a target ablation metric, monitors lesion formation, and adjusts therapy delivery based on intra-therapeutic properties to achieve a desired therapeutic endpoint.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If predetermined open-loop ablation therapy is delivered, then the treatment protocol is simple and fast to implement, but the therapy cannot adapt to real-world circumstances such as patient anatomy and tissue response
Solution Approach 1:
The system implements closed-loop feedback by continuously monitoring intra-therapeutic tissue properties (impedance, contact force, catheter stability, EGM signal morphology) during ablation therapy and using this feedback to dynamically adjust treatment parameters. The processor compares real-time measurements against target values and modifies delivery parameters accordingly, enabling the system to adapt to actual tissue response rather than following a fixed predetermined protocol.
Solution Approach 2:
The ablation system performs self-adjustment by automatically modifying its own delivery parameters based on real-time tissue feedback. The closed-loop processor autonomously determines optimal treatment parameters without requiring continuous manual intervention, allowing the system to self-optimize the ablation therapy based on actual tissue conditions and response during the procedure.
2Manufacturing precision
If fixed number of PFA bursts is delivered, then the treatment time is predictable and short, but the therapy does not account for variations in tissue response and anatomy
Solution Approach 1:
The system transitions from static fixed-duration therapy to dynamic adaptive therapy by continuously adjusting delivery parameters based on real-time tissue response. The processor monitors intra-therapeutic properties and dynamically modifies the number and timing of PFA bursts, contact force thresholds, and other parameters to achieve precise lesion formation while adapting to actual tissue characteristics and response during the procedure.
Solution Approach 2:
The closed-loop system changes multiple treatment parameters dynamically during therapy based on real-time feedback. This includes adjusting the number of PFA bursts, inter-burst intervals, contact force requirements, and delivery timing to optimize lesion formation precision. The system modifies these parameters according to measured tissue properties and response, allowing precise treatment while adapting to variations in patient anatomy and tissue characteristics.
3Reliability
If ablation therapy is delivered without real-time monitoring, then the procedure is simpler to perform, but the lesion formation confidence is reduced
Solution Approach 1:
The system implements real-time feedback monitoring of multiple tissue properties including impedance changes, contact force stability, catheter position stability, and EGM signal morphology. This feedback is continuously processed by the closed-loop processor to assess lesion formation progress and confidence, providing objective criteria for determining when transmural lesions have been successfully created without requiring extensive operator experience or judgment.
Solution Approach 2:
The system replaces reliance on operator skill and experience with automated computational analysis of tissue response. The closed-loop processor automatically interprets complex multi-parameter tissue feedback signals and makes treatment decisions based on algorithmic analysis rather than human judgment, increasing reliability while maintaining ease of operation through automation.
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 ensures precise and customized ablation therapy by dynamically adjusting treatment based on real-time tissue feedback, enhancing the creation of transmural lesions with high confidence.
Implementation Method 1
One form of ablation therapy is radiofrequency ablation (RFA). In RFA, heat produced by radiofrequency (RF) energy is used to destroy tissue and create transmural lesions.
Implementation Method 2
Electroporation is a non-thermal ablation technique that involves applying strong electric fields that induce pore formation in the cellular membrane.
Data Source
AI summary
An ablation system includes an ablation generator, catheter, and a closed-loop ablation processor operably coupled thereto. The processor receives baseline tissue properties, such as baseline tissue impedance, tissue thickness, tissue anatomical location, tissue type, catheter-tissue contact force, catheter stability against the tissue, and baseline electrogram signal morphology. The processor also receives waveform parameters for the generator. Using the baseline tissue properties and the waveform parameters, the processor determines whether pulsed field or radiofrequency ablation therapy should be delivered and computes corresponding target ablation metric(s), such as a target ablation index. The processor then commands the generator to deliver ablation therapy to the tissue and monitors lesion formation using intra-therapeutic tissue properties (and waveform parameters) to compute intra-therapeutic ablation metric(s) and comparing the intra-therapeutic ablation metric(s) to the target ablation metric(s). Ablation therapy ceases when the intra-therapeutic ablation metric(s) satisfy the target ablation metric(s).