Pericardial Puncture Device Alignment With Electrical Indicators

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Solution Overview

Problem

Existing medical devices lack a reliable method to accurately position a radiofrequency puncture electrode relative to the distal end of an introducer during pericardial puncture, making it difficult to ensure precise delivery of RF energy and enhancing the risk of tissue damage.

Innovation Solution

A system comprising an introducer and puncture device with indicator electrodes that are electrically connected to an indicator system, allowing for alignment and activation of an indicator (e.g., a light) when the electrodes are longitudinally aligned, providing visual confirmation of the puncture device's position relative to the introducer.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If visual alignment methods are used to position the puncture device, then the positioning accuracy is insufficient, but adding indicator electrodes and electrical connection improves positioning precision

Engineering Contradiction:
Improvepositioning accuracyVSAvoiddevice complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent replaces visual alignment methods with an electrical detection system. Indicator electrodes on the puncture device and introducer establish electrical connection when properly aligned, providing precise positional feedback without relying on visual estimation. This substitutes mechanical/visual alignment with electrical field-based detection.

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

Solution Approach 2:

The electrical connection between indicator electrodes provides immediate feedback to the operator about the relative position of the puncture device and introducer. When the electrodes connect, it confirms proper alignment, creating a closed-loop feedback system that enhances positioning accuracy.

Inventive Principle:
Principle #23Feedback

2Object-affected harmful factors

If the puncture device is advanced without precise positioning indication, then the procedure is simpler, but the risk of tissue damage increases

Engineering Contradiction:
Improvetissue damage riskVSAvoidoperational simplicity
Core Design Contradiction:
Object-affected harmful factorsVSEase of operation

Solution Approach 1:

The system establishes electrical connection between indicator electrodes before the actual puncture procedure begins. This preliminary alignment confirmation ensures the puncture device is correctly positioned relative to the introducer before any tissue-contacting action occurs, preventing mispositioning-related tissue damage.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The indicator electrodes serve as intermediary elements that mediate between the operator and the puncture procedure. They provide an intermediate verification step (electrical connection) that confirms proper positioning without requiring the operator to directly assess complex spatial relationships.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Measurement precision

If indicator electrodes are added to both introducer and puncture device, then positioning precision improves, but device complexity increases

Engineering Contradiction:
Improvealignment accuracyVSAvoiddevice complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent replaces complex mechanical alignment mechanisms with simple electrical contact detection. Instead of using mechanical interlocks, guides, or visual markers requiring complex positioning, the system uses straightforward electrical connection between two electrodes to indicate alignment, achieving precision with minimal added complexity.

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

Enables precise positioning of the RF puncture electrode, ensuring accurate delivery of RF energy to the target tissue while minimizing tissue damage and improving procedural safety.

Implementation Method 1

When the second indicator electrode is in electrical contact with the first indicator electrode, the impedance of the first impedance sensor can approximate the impedance of the second impedance sensor. The indicator can be activated when the impedance of the first impedance sensor approximates the impedance of the second impedance sensor.

Methodology Applied
Scientific EffectElectrical connection: Conduction (electrical)

Data Source

PatentEP4178477B1System of medical devices for pericardial puncture
Publication Date: 2025.10.01 BOSTON SCI MEDICAL DEVICE LTD
  • EP4178477B1 patent drawingFigure 1
  • EP4178477B1 patent drawingFigure 2~3
  • EP4178477B1 patent drawingFigure 4~5

AI summary

A system of medical devices includes an introducer, a puncture device, and an indicator system. The introducer has a lumen extending therethrough from a proximal end thereof a distal end thereof, and includes a first indicator electrode that faces radially inwardly toward the lumen. The puncture device has a radiofrequency puncture electrode at a distal end thereof, and a second indicator electrode that is positioned proximal of the radiofrequency puncture electrode and that faces radially outwardly.