Energized Flexible Wire Aorta Left Atrium Perforation

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Solution Overview

Problem

Conventional methods for creating perforations between the aorta and left atrium, such as using an LVAD catheter through the mitral valve, are limited by issues like effusions, valve stenosis, hematoma, and vessel dissection, and do not allow for direct access while avoiding the mitral and aortic valves and left ventricle.

Innovation Solution

A system comprising a flexible wire and a dilator is used to create a direct perforation between the aorta and left atrium, where the flexible wire, when energized, creates a perforation, and the dilator, with a predetermined curvature, directs and enlarges the perforation, allowing for therapeutic device placement without traversing the mitral and aortic valves.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional methods using LVAD catheter through mitral valve are used, then perforation between aorta and left atrium can be created, but complications such as effusions, valve stenosis, hematoma, and vessel dissection occur

Engineering Contradiction:

Improveperforation creation successVSAvoidcomplications (effusions, valve stenosis, hematoma, vessel dissection)

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The procedure is divided into distinct stages: first creating a transseptal perforation from right atrium to left atrium, then creating a second perforation from left atrium to aorta. This segmentation allows each perforation to be created independently with appropriate positioning, avoiding the need to traverse valves and reducing complications

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The flexible wire with dilator acts as an intermediary tool that enables direct creation of the aorta-left atrium perforation without requiring catheter traversal through mitral and aortic valves. The wire can be positioned and energized to create the perforation directly, eliminating the harmful valve traversal path

Inventive Principle:

Principle #24Intermediary (Mediator)

2Object-affected harmful factors

If direct access between aorta and left atrium is achieved, then valve traversal is avoided, but new methods and tools are required

Engineering Contradiction:

Improvevalve damage avoidanceVSAvoidflexible wire and dilator system

Core Design Contradiction:

Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The invention replaces the mechanical catheter-based approach with a flexible wire that can be energized to create perforations. This substitution allows direct access without mechanical traversal of valves, using energy delivery (such as RF or laser) to create the perforation pathway

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The flexible wire incorporates predetermined curvatures that guide it through the vasculature and into the heart chambers. These curved configurations enable the wire to navigate anatomical pathways and position the distal tip accurately at the aorta-left atrium interface without rigid mechanical structures

Inventive Principle:

Principle #14Spheroidality (Curvature)

3Ease of operation

If flexible wire is used to create perforation, then direct access is achieved, but precise positioning and control are required

Engineering Contradiction:

Improvedirect perforation creationVSAvoidperforation positioning accuracy

Core Design Contradiction:

Ease of operationVSManufacturing precision

Solution Approach 1:

The flexible wire is pre-configured with specific curvatures and the dilator is pre-shaped to facilitate accurate positioning. These preliminary configurations ensure that when the wire is advanced, it naturally follows the desired path to the target location, reducing the need for complex real-time adjustments

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The system incorporates visualization and pressure sensing capabilities that provide real-time feedback during wire advancement. This feedback allows operators to monitor wire position and adjust accordingly, ensuring accurate positioning of the distal tip at the aorta-left atrium interface before energizing to create the perforation

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

This method enables safe and effective creation of perforations between the aorta and left atrium, reducing the risk of complications associated with conventional methods and allowing for the placement of therapeutic devices like LVADs without damaging surrounding vasculature.

Implementation Method 1

the flexible wire, when energized, creates a perforation

Methodology Applied

Scientific EffectAblation: Ablation

Data Source

PatentUS20230233254A1Surgical perforation between the aorta and left atrium

Publication Date: 2023.07.27 BOSTON SCI MEDICAL DEVICE LTD

AI summary

Apparatuses and methods are disclosed for the perforation of a communication between the aorta and left atrium. The method includes introducing the apparatus, positioning the apparatus at a location along the aorta, and energizing the apparatus to create a perforation. For example, one method may include: introducing a flexible wire into the left atrium, advancing a dilator along the flexible wire to position the flexible wire adjacent a selected location along the aorta and energizing the flexible wire to create a perforation from the left atrium into the aorta.