Cryoablation Treatment Time Determination Using Mapping Array Feedback

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Solution Overview

Problem

Current medical procedures using catheters face challenges in accurately identifying and monitoring tissue proximity during treatment, particularly in avoiding damage to non-target tissues like the phrenic nerve during cryoablation.

Innovation Solution

A system comprising a cryoballoon, a mapping array with electrodes, a catheter, and hardware processors is used to determine a treatment time for cryoablation. The system positions the cryoballoon and mapping array adjacent to the target tissue, generates pacing signals, determines the minimum activation energy of non-target tissue, and calculates the treatment time based on the activation energy and signal artifacts detected during refrigerant application.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If cryoablation is applied to treat target tissue, then the treatment effectiveness is improved, but the risk of damaging non-target tissues increases

Engineering Contradiction:

Improvetreatment effectivenessVSAvoiddamage to non-target tissues

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The system performs preliminary mapping of the treatment zone and determination of minimum activation energy before applying cryoablation. By pre-identifying the location and electrical properties of non-target tissues through mapping array measurements, the system can set appropriate treatment parameters to avoid damaging these structures while still achieving effective treatment of the target tissue.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The system continuously monitors electrical signals during cryoablation and uses this feedback to determine when to terminate treatment. The mapping array detects changes in electrical properties that indicate the treatment is approaching non-target tissues or has been sufficiently effective, allowing real-time adjustment or termination of the ablation process to prevent harm to non-target structures.

Inventive Principle:

Principle #23Feedback

2Manufacturing precision

If treatment time is extended to ensure complete ablation, then the treatment completeness is improved, but the risk of damaging non-target tissues increases

Engineering Contradiction:

Improvetreatment completenessVSAvoiddamage to non-target tissues

Core Design Contradiction:

Manufacturing precisionVSObject-affected harmful factors

Solution Approach 1:

The system replaces mechanical/time-based treatment control with electrical parameter-based control. Instead of using fixed time durations or mechanical pressure, the system uses electrical signal analysis and minimum activation energy thresholds to determine treatment duration. This allows precise control of treatment length based on actual tissue response rather than arbitrary time intervals, ensuring completeness while preventing damage to non-target tissues.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

3Measurement precision

If mapping array is used to identify non-target tissues, then the measurement precision is improved, but the device complexity increases

Engineering Contradiction:

Improveidentification accuracy of non-target tissuesVSAvoidsystem complexity

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

The mapping array serves multiple functions: it maps the treatment zone geometry, measures electrical properties of tissues, identifies non-target structures, and provides data for treatment parameter determination. By consolidating these functions into a single multi-functional component rather than requiring separate devices for each measurement type, the system achieves high measurement precision while limiting the increase in overall device complexity.

Inventive Principle:

Principle #6Universality (Multi-functionality)

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 system enables precise determination of treatment time for cryoablation, reducing the risk of damaging non-target tissues by accurately monitoring the effects of the treatment and automatically controlling the cryoballoon's activation.

Implementation Method 1

activate the cryoballoon to apply a liquid refrigerant to the treatment zone

Methodology Applied

Scientific EffectCryoablation: Freezing

Implementation Method 2

generate a pacing signal at the one or more electrodes; detect, at a second time, an artifact in a signal of the one or more electrodes

Methodology Applied

Scientific EffectElectrical signal detection: Electric Field

Data Source

PatentUS20250049490A1Systems and methods for electrophysiological treatment

Publication Date: 2025.02.13 BIOZONAL ID LLC

AI summary

Systems and methods for determining a treatment time for treatment zone of a target tissue are disclosed herein. In some embodiments, a system may include a cryoballoon, a mapping array, a catheter, and one or more hardware processors. The hardware processors may generate a pacing signal at the electrodes of the mapping array at the treatment zone and determine a minimum activation energy of a non-target tissue. The processors may activate the cryoballoon at a first time and detect an artifact in the electrical signals collected from the electrodes of the mapping array at a second time. Based on the minimum activation energy of the non-target tissue and the difference between the second time and the first time, the processors may determine an optimal treatment time for the treatment zone of the target tissue.