Cardiac Electrogram-Guided Navigation for Left Atrial Appendage Closure

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Solution Overview

Problem

Current minimally invasive procedures for closing the left atrial appendage are cumbersome, require large incisions, and pose risks due to the need for thoracotomy or transseptal penetration, and lack effective navigation and visualization methods, especially in the slippery and fluid-filled pericardial space, leading to potential trauma and incomplete closure.

Innovation Solution

A navigation and tissue capture system that utilizes the innate electrical activity of cardiac tissues to guide devices to the left atrial appendage, employing electrodes to distinguish between different cardiac signals and facilitate minimally invasive access through a sub-xiphoid approach, allowing for precise closure without the need for thoracotomy or transseptal penetration.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Illumination intensity

If a thoracotomy is performed to access the left atrial appendage, then direct visualization and surgical access are improved, but patient trauma and procedural risk are significantly increased

Engineering Contradiction:
ImprovevisualizationVSAvoidpatient trauma
Core Design Contradiction:
Illumination intensityVSObject-affected harmful factors

Solution Approach 1:

The patent replaces the mechanical thoracotomy approach with a percutaneous needle-based system that uses electrical field detection (electrograms) to navigate and identify the left atrial appendage, eliminating the need for large incisions and chest opening while maintaining access capability

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

Solution Approach 2:

The patent introduces electrogram monitoring as an intermediary detection method that allows indirect identification and navigation to the left atrial appendage through electrical signal detection, replacing direct visual inspection that would require thoracotomy

Inventive Principle:
Principle #24Intermediary (Mediator)

2Ease of operation

If a transseptal penetration is performed to access the left atrial appendage, then minimally invasive access is achieved, but risks of clot dislodgement and endocardial injury are increased

Engineering Contradiction:
Improveminimally invasive accessVSAvoidclot dislodgement risk
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The patent uses electrogram monitoring as an intermediary to guide needle placement externally through the pericardium, avoiding the need for transseptal penetration and intracardiac navigation that could dislodge clots or injure the endocardium

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent extracts the navigation and detection function from the intracardiac space to the pericardial space, performing all detection and guidance maneuvers outside the heart chambers to eliminate risks associated with intracardiac manipulation

Inventive Principle:
Principle #2Taking out (Extraction)

3Object-affected harmful factors

If thoracoscopic approach is used to close the left atrial appendage, then chest opening is avoided, but lung deflation and full anesthesia are still required

Engineering Contradiction:
Improvechest traumaVSAvoidanesthesia requirement
Core Design Contradiction:
Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The patent replaces the thoracoscopic mechanical visualization system with an electrical field-based detection system using electrograms, enabling navigation and identification without lung deflation or full anesthesia, reducing procedural complexity and patient risk

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

4Object-affected harmful factors

If percutaneous approach is used to access the left atrial appendage, then patient trauma is reduced, but navigation and visualization in the pericardial space become difficult

Engineering Contradiction:
Improvepatient traumaVSAvoidnavigation difficulty
Core Design Contradiction:
Object-affected harmful factorsVSDifficulty of detecting and measuring

Solution Approach 1:

The patent introduces electrogram monitoring as an intermediary detection system that provides real-time electrical signal feedback from the pericardial space, enabling accurate navigation and identification of the left atrial appendage without requiring visual inspection or complex imaging

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent implements continuous electrogram signal feedback to guide needle advancement and positioning in the pericardial space, allowing real-time adjustment of the approach based on detected electrical signals from cardiac structures

Inventive Principle:
Principle #23Feedback

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 stable closure of the left atrial appendage with reduced risk and trauma, allowing for procedures under local or general anesthesia without deflating the lungs, using a percutaneous approach that improves visualization and navigation within the pericardial space.

Implementation Method 1

monitoring electrograms in tissue proximate the internal body location using the capture shaft electrode and the first electrode

Methodology Applied
Scientific EffectElectrical activity detection: Conduction (electrical)

Data Source

PatentUS9848898B2Navigation and tissue capture systems and methods
Publication Date: 2017.12.26 AEGIS MEDICAL INNOVATIONS
  • US9848898B2 patent drawing
  • US9848898B2 patent drawing
  • US9848898B2 patent drawing

AI summary

Navigation and tissue capture systems and methods for navigation to and/or capture of selected tissue using the innate electrical activity of the selected tissue and/or other tissue are described. In the context of left atrial appendage closure, the systems and methods can be used to navigate to the left atrial appendage and capture/control the appendage while a closure instrument (suture, clip, ring) is placed over the appendage and tightened down or a closure method (ablation, cryogenic procedures, stapling, etc.) is performed to close the left atrial appendage. The use of innate electrical activity for navigating devices may be used in connection with other tissues and/or areas of the body.