Multi-lumen Catheter for Mitral Valve Guide Wire Navigation

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Solution Overview

Problem

Current transcatheter procedures for treating cardiac dysfunctions face challenges in precisely positioning guide wires around atrioventricular heart valves, particularly the mitral valve, due to the presence of chordae tendineae, which complicates navigation and increases the risk of errors and procedural time.

Innovation Solution

A device with a multi-lumen introducer catheter and adjustable guide catheters allows for precise navigation and positioning of guide wires around the mitral valve without penetrating the chordae tendineae, using a capture system to secure the guide wires in place, enabling correct deployment of prosthetic systems for transcatheter valve replacement.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If guide wires are positioned manually in cardiac chambers, then the procedure can be performed with simple equipment, but the positioning precision is low and procedural time is extended

Engineering Contradiction:
Improveguide wire positioning precisionVSAvoidprocedural time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The device pre-forms the guide wire distal portion into a specific configuration (such as a loop or arc) before insertion, which automatically guides the wire along the desired path around the mitral valve when deployed. This preliminary shaping eliminates the need for manual positioning adjustments during the procedure, thereby improving positioning precision while reducing procedural time

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent introduces a delivery catheter as an intermediary device that carries and deploys the guide wire. The catheter provides a controlled delivery mechanism that positions the pre-formed guide wire configuration accurately in the cardiac chamber, eliminating the need for direct manual manipulation and improving both precision and efficiency

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If guide wires are positioned around the mitral valve, then accurate deployment of prosthetic systems is enabled, but the presence of chordae tendineae complicates navigation and increases error risk

Engineering Contradiction:
Improvedeployment accuracyVSAvoidnavigation complexity due to chordae tendineae
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The guide wire is designed with non-uniform properties: the distal portion is made more flexible and pre-formed into a specific configuration, while the proximal portion remains stiffer for easy manipulation. This local differentiation allows the wire to navigate around the chordae tendineae smoothly without penetrating them, while maintaining controllability during insertion and deployment

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The guide wire distal portion is pre-formed into a curved or looped configuration that matches the natural curvature of the mitral valve annulus. This curved geometry allows the wire to follow the anatomical path around the valve without intersecting the chordae tendineae, thereby improving safety and deployment accuracy

Inventive Principle:
Principle #14Spheroidality (Curvature)

3Measurement precision

If a multi-lumen introducer catheter with adjustable guide catheters is used, then precise navigation and positioning is achieved, but device complexity increases

Engineering Contradiction:
Improveguide wire positioning precisionVSAvoiddevice structure complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The introducer catheter is designed with multiple lumens that can accommodate different guide catheters and delivery systems. This multi-functional design allows the same introducer to be used for various transcatheter procedures, including mitral valve interventions, aortic valve interventions, and other cardiac procedures, thereby justifying the increased complexity through broader applicability

Inventive Principle:
Principle #6Universality (Multi-functionality)

Solution Approach 2:

The device is divided into modular components: the introducer catheter, adjustable guide catheters, and delivery systems can be independently selected and combined based on procedural requirements. This segmentation allows clinicians to use only the necessary components for each specific procedure, reducing the effective complexity while maintaining the capability for precise navigation

Inventive Principle:
Principle #1Segmentation

Data Source

PatentEP2922501B1Device for the deployment of a system of guide wires within a cardiac chamber for implanting a prosthetic heart valve
Publication Date: 2016.11.09 INNOVHEART SRL
  • EP2922501B1 patent drawingFigure 1~2
  • EP2922501B1 patent drawingFigure 3~4
  • EP2922501B1 patent drawingFigure 5~6

AI summary

A device (1) for the deployment of a system of guide wires within a cardiac chamber comprises an introducer catheter (10) having two or more through lumens, within which at least two first guide catheters (14) are positioned. These guide catheters have respective deflected or deflectable distal ends adapted to emerge from the distal end of the introducer catheter to convey and direct the distal ends of respective guide wires, placed within the guide catheters, towards a capture member (22) of a capture system which is provided within the introducer catheter. The capture system can be selectively drawn out of and retracted into the introducer catheter. The capture member is provided with distal gripping means for capturing the distal ends of the guide wires and drawing them into the introducer catheter.