Electrode Tissue Proximity Assessment via Electrical Coupling Index

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Solution Overview

Problem

Conventional systems for assessing the proximity of a catheter electrode to tissue are inadequate, as they often provide proximity information too late to be useful, and fail to accurately determine the electrode's position before contact is made, leading to potential tissue damage or ineffective treatments.

Innovation Solution

A system and method using an electronic control unit (ECU) to calculate an electrical coupling index (ECI) based on complex impedance components, allowing for real-time assessment of the electrode's proximity to tissue, enabling adjustments in approach speed and angle before contact.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If discrete force measurements using strain gauges or pressure inducers are used to assess contact between electrode and tissue, then contact detection capability is improved, but proximity information is obtained too late to be useful for adjusting approach parameters

Engineering Contradiction:
Improvecontact detection capabilityVSAvoidtiming of proximity information
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent applies preliminary action by measuring electrical impedance before physical contact occurs. The system detects changes in impedance that indicate the electrode is approaching tissue, allowing the operator to adjust approach parameters in advance. This is achieved by continuously monitoring impedance values and comparing them to predetermined thresholds that correspond to specific proximity states, enabling proactive adjustment rather than reactive response after contact.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent replaces mechanical force measurement systems (strain gauges, pressure inducers) with an electrical measurement system. Instead of mechanically sensing contact forces, the system uses electrical impedance measurements to detect proximity. This substitution allows for earlier detection because electrical field changes occur before physical contact, providing timely proximity information without the latency of mechanical contact detection.

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

2Object-affected harmful factors

If the electrode is positioned too far from the tissue, then tissue damage risk is reduced, but treatment effectiveness decreases due to insufficient energy delivery

Engineering Contradiction:
Improvetissue damage riskVSAvoidtreatment effectiveness
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The patent implements feedback by continuously monitoring electrical impedance values and providing real-time information about electrode-tissue proximity. The system compares measured impedance to predetermined thresholds and provides feedback indicators (such as visual or audible signals) that guide the operator in adjusting electrode position. This feedback loop enables the operator to maintain the optimal distance where treatment effectiveness is maximized while minimizing tissue damage risk.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The patent utilizes parameter changes in electrical impedance to detect and respond to proximity variations. As the electrode approaches tissue, the electrical impedance changes in a predictable manner. The system monitors these parameter changes and uses them to determine proximity state, enabling dynamic adjustment of positioning to achieve the optimal balance between effectiveness and safety.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If the catheter electrode contacts tissue with excessive force, then secure contact is achieved, but tissue perforation or damage may occur

Engineering Contradiction:
Improvecontact stabilityVSAvoidtissue perforation risk
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent applies preliminary action by detecting proximity through impedance changes before excessive contact force is applied. The system identifies when the electrode is approaching the tissue boundary by monitoring impedance trends, allowing the operator to reduce approach speed or adjust positioning in advance. This prevents the situation where excessive force would be applied and causes tissue damage.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent implements preliminary anti-action by providing warning indicators when impedance values suggest the electrode is nearing tissue contact. The system counteracts potential harmful effects by alerting the operator to slow down or adjust positioning before dangerous contact forces can develop. This proactive warning system prevents the harmful action of excessive force application.

Inventive Principle:
Principle #9Preliminary anti-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

Enables precise and safe delivery of ablation energy by providing real-time proximity feedback, reducing the risk of tissue damage and improving treatment efficacy by determining the optimal contact conditions before electrode-tissue interaction.

Implementation Method 1

an electronic control unit (ECU) to calculate an electrical coupling index (ECI) based on complex impedance components

Methodology Applied
Scientific EffectElectrical Impedance: Electrical Resistance

Data Source

PatentUS10362959B2System and method for assessing the proximity of an electrode to tissue in a body
Publication Date: 2019.07.30 ST JUDE MEDICAL ATRIAL FIBRILLATION DIVISION INC
  • US10362959B2 patent drawing
  • US10362959B2 patent drawing
  • US10362959B2 patent drawing

AI summary

A method and system for assessing proximity between an electrode and tissue is provided. The system includes an electronic control unit (ECU). The ECU is configured to acquire values for first and second components of a complex impedance between the electrode and the tissue, and to calculate an electrical coupling index (ECI) responsive to the first and second values. The ECU is further configured to process the ECI to determine the proximity of the electrode to the tissue. The ECU may be configured to calculate an electrical coupling index rate (ECIR) based on the calculated ECI and information relating to the change in location of the electrode, and to assess proximity based on the ECIR. Alternatively, the ECU may be configured to assess the proximity using the calculated ECI, as opposed to the ECIR.