Lesion Size Estimation Using Non-Linear Force Power Integration

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Solution Overview

Problem

Existing methods for estimating the size of lesions created during cardiac tissue ablation using radiofrequency energy are inexact, as they assume a linear relationship between force, power, and time, which is highly non-linear in reality.

Innovation Solution

A method involving the measurement of contact force and power during ablation, with the cessation of the procedure when a desired lesion size is reached, estimated using an integral of the product of contact force raised to a non-unity exponent and power raised to another non-unity exponent, providing more accurate estimates of lesion volume, depth, or diameter.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Device complexity

If a linear relationship between force, power, and time is assumed for lesion size estimation, then the estimation model is simple, but the accuracy of lesion size estimation deteriorates

Engineering Contradiction:
Improveestimation model complexityVSAvoidlesion size estimation accuracy
Core Design Contradiction:
Device complexityVSMeasurement precision

Solution Approach 1:

The patent changes the parameters of the estimation model by introducing non-unity exponents (α and β) for force and power respectively, transforming the linear relationship into a non-linear power law relationship. This allows the model to capture the actual non-linear behavior of lesion formation while maintaining a relatively simple mathematical structure.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent makes the estimation model dynamic by allowing the exponents α and β to be determined from experimental data rather than being fixed. This enables the model to adapt to different tissue types and ablation conditions, improving accuracy without requiring complex real-time calculations.

Inventive Principle:
Principle #15Dynamics

2Measurement precision

If non-unity exponents are used in the lesion size estimation equation, then the accuracy of lesion size estimation is improved, but the complexity of the estimation model increases

Engineering Contradiction:
Improvelesion size estimation accuracyVSAvoidestimation model complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent modifies the parameters of the estimation equation by introducing non-unity exponents α and β. These parameters are determined through experimental data analysis and can be pre-calculated for different tissue types, avoiding the need for complex real-time computations while maintaining high accuracy.

Inventive Principle:
Principle #35Parameter changes

3Manufacturing precision

If ablation continues until a desired lesion size is reached using non-unity exponents, then the precision of lesion size control is improved, but the time required for ablation increases

Engineering Contradiction:
Improvelesion size control precisionVSAvoidablation time
Core Design Contradiction:
Manufacturing precisionVSDuration of action of moving object

Solution Approach 1:

The patent implements a feedback control mechanism where the ablation process is monitored continuously and terminated when the estimated lesion size reaches the desired threshold. This feedback approach ensures precise lesion size control while minimizing unnecessary ablation time by stopping the procedure as soon as the target is achieved.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The patent performs preliminary calculations of the integral term before the ablation procedure to determine the desired ablation time. This allows the operator to plan the ablation duration in advance based on tissue characteristics and desired lesion size, reducing overall procedure time while maintaining precision.

Inventive Principle:
Principle #10Preliminary action

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

This approach results in more precise control over lesion size, with equations (2), (3), and (4) providing good estimates of lesion size, as validated by experimental data and regression analysis, improving the accuracy of ablation procedures.

Implementation Method 1

electromagnetic radiofrequency (RF) energy is injected from a catheter electrode into the tissue, causing ablation and production of a lesion

Methodology Applied
Scientific EffectJoule heating: Joule Heating

Implementation Method 2

electromagnetic radiofrequency (RF) energy is injected from a catheter electrode into the tissue, causing ablation

Methodology Applied
Scientific EffectDielectric heating: Dielectric Heating

Implementation Method 3

measuring a contact force applied during the time period

Methodology Applied
Scientific EffectForce measurement: Force

Data Source

PatentUS11304752B2Estimation of lesion size
Publication Date: 2022.04.19 BIOSENSE WEBSTER (ISRAEL) LTD
  • US11304752B2 patent drawing
  • US11304752B2 patent drawing
  • US11304752B2 patent drawing

AI summary

A method, consisting of ablating tissue for a time period, measuring a contact force applied during the time period, and measuring a power used during the time period. The method further includes ceasing ablating the tissue when a desired size of a lesion produced in the tissue, as estimated using an integral over the time period of a product of the contact force raised to a first non-unity exponent and the power raised to a second non-unity exponent, is reached.