Medical Dilator EAM Electrode for Non-Fluoroscopic Tip Localization

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Solution Overview

Problem

Existing medical dilation procedures lack effective non-fluoroscopic methods for precise visualization and localization of the dilator tip within the body, particularly during transseptal procedures, which can lead to potential damage to non-target tissues.

Innovation Solution

A medical dilator equipped with an electroanatomical mapping (EAM) electrode allows for non-fluoroscopic visualization and localization of the dilator tip using an EAM system, enabling precise positioning and tracking of the dilator tip relative to target and non-target tissues.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If traditional fluoroscopic guidance is used for dilator positioning, then real-time visualization is achieved, but radiation exposure and procedural complexity increase

Engineering Contradiction:
Improvedilator tip localization precisionVSAvoidguidance system complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent replaces the mechanical/fluoroscopic guidance system with an electroanatomical mapping system that uses electrical signals to localize the dilator tip. The EAM electrode detects electrical field interactions with surrounding tissues, providing precise three-dimensional positioning without requiring fluoroscopic radiation or complex mechanical guidance structures.

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

Solution Approach 2:

The patent introduces an intermediary EAM electrode that acts as a mediator between the dilator tip and the external mapping system. This electrode captures electrical field information and transmits it through the dilator shaft to the EAM system, enabling indirect but precise localization of the tip position and orientation in three-dimensional space.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Measurement precision

If fluoroscopy is used for visualization, then accurate tip positioning is achieved, but radiation exposure to patient and operator increases

Engineering Contradiction:
Improvetip positioning accuracyVSAvoidradiation exposure
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The patent eliminates fluoroscopic radiation by substituting it with an electrical field-based mapping system. The EAM electrode uses electrical signals to interact with conductive tissues, providing visualization and positioning data without any ionizing radiation exposure to the patient or operator.

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

3Measurement precision

If the dilator tip is made more prominent for better visualization, then localization improves, but the risk of damaging non-target tissues increases

Engineering Contradiction:
Improvetip localization precisionVSAvoidtissue damage risk
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The patent implements continuous feedback through the EAM system that monitors the electrical field interactions around the dilator tip in real-time. This feedback provides precise information about the tip's position and orientation, allowing the operator to adjust positioning carefully and avoid contact with non-target tissues while maintaining accurate localization.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The patent replaces mechanical prominence (larger, more visible tips) with an electrical field-based detection system. The EAM electrode provides precise localization through electrical field mapping, allowing for delicate tip positioning without the mechanical prominence that could accidentally damage surrounding tissues.

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

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

Enhances procedural safety by ensuring accurate placement of the dilator tip, minimizing the risk of tissue damage and improving the precision of surgical perforations.

Implementation Method 1

A medical dilator equipped with an electroanatomical mapping (EAM) electrode allows for non-fluoroscopic visualization and localization of the dilator tip using an EAM system

Methodology Applied
Scientific EffectElectroanatomical mapping: Electric Field

Data Source

PatentEP3999163B1Medical dilator, system and kit for medical dilation
Publication Date: 2025.08.27 BOSTON SCI MEDICAL DEVICE LTD
  • EP3999163B1 patent drawingFigure 1
  • EP3999163B1 patent drawingFigure 2
  • EP3999163B1 patent drawingFigure 3A~3C

AI summary

A medical dilator includes an elongate member having a proximal end portion, an opposed distal end portion, and a lumen extending through the elongate member from the proximal end portion to the distal end portion. A dilating tip is at the distal end portion. The dilating tip has a first end of enlarged cross- sectional area and tapers going in the distal direction to a second end of reduced cross-sectional area. At least a first electrode is associated with the dilating tip. An electrical conductor is electrically connected to the first electrode and extends proximally from the first electrode towards the proximal end portion for electrical connection with an electro anatomical mapping system.