Catheter-Based Mitral Valve Annuloplasty Using Radiopaque Markers

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Solution Overview

Problem

Current treatments for mitral valve leakage, such as open-heart surgical procedures, are invasive and carry risks of infection, neurological deficits, and significant recovery time, making them unsuitable for all patients, especially those who are frail or have severe heart failure.

Innovation Solution

A minimally invasive system using catheter devices with radiopaque markers and guide wires to accurately introduce elements, such as anchors, into the mitral valve annulus to plicate tissue and reduce regurgitation, allowing for precise correction of mitral valve leakage without open-heart surgery.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If open-heart surgical procedures are used to correct mitral valve leakage, then effective correction can be achieved, but the risk of complications and recovery time increase significantly

Engineering Contradiction:

Improveeffectiveness of mitral valve correctionVSAvoidrisk of complications and recovery time

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent replaces traditional open-heart surgical mechanical procedures with a minimally invasive percutaneous system that uses catheter-based delivery of anchors and plicating elements. This substitution eliminates the need for sternotomy and cardiopulmonary bypass while achieving the same therapeutic effect of correcting mitral valve leakage through tissue plication and annulus tightening.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent introduces radiopaque markers as intermediary elements that enable visualization and precise positioning of catheter devices and anchors within the heart. These markers serve as mediators between the operator and the internal cardiac structures, allowing accurate placement without direct visual exposure during open surgery.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Object-affected harmful factors

If minimally invasive catheter-based methods are used, then recovery time and surgical risk are reduced, but positioning precision and accuracy of element insertion decrease

Engineering Contradiction:

Improvesurgical risk and recovery timeVSAvoidpositioning precision of element insertion

Core Design Contradiction:

Object-affected harmful factorsVSManufacturing precision

Solution Approach 1:

The patent employs radiopaque markers that appear as distinct radiographic signals (analogous to color changes in visual detection) under fluoroscopic imaging. These markers provide high-contrast visualization that enables precise tracking of catheter position, anchor placement, and plicating element deployment, thereby maintaining positioning accuracy despite the minimally invasive approach.

Inventive Principle:

Principle #32Color changes

Solution Approach 2:

The patent implements a feedback mechanism through radiopaque markers that allow real-time visualization and adjustment of catheter and anchor positions. The operator can observe the location and orientation of markers during the procedure and make corrective adjustments to achieve precise element insertion, ensuring accurate tissue plication and annulus tightening.

Inventive Principle:

Principle #23Feedback

3Ease of operation

If traditional open-heart surgery is performed, then complete access to the mitral valve is achieved, but the invasiveness and patient trauma increase

Engineering Contradiction:

Improveaccess to mitral valveVSAvoidinvasiveness and patient trauma

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The patent extracts the essential function of mitral valve access from the context of open-heart surgery. By delivering anchors and plicating elements percutaneously through catheters, the system separates the therapeutic intervention from the invasive surgical approach, achieving complete functional access without the trauma of sternotomy and open chest surgery.

Inventive Principle:

Principle #2Taking out (Extraction)

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 accurate and minimally invasive correction of mitral valve leakage, reducing the risk of complications associated with traditional open-heart surgery and improving heart function by enhancing mitral valve closure, thus addressing the limitations of existing treatments.

Implementation Method 1

The first catheter device includes first, second and third spaced apart radiopaque markers at the first distal end portion. The second catheter device includes a fourth radiopaque marker at the second distal end portion.

Methodology Applied

Scientific EffectRadiopaque marker visualization: X-Ray

Data Source

PatentUS8864822B2Devices and methods for introducing elements into tissue

Publication Date: 2014.10.21 EDWARDS LIFESCIENCES CORP

AI summary

Systems, devices and methods for securing tissue including the annulus of a mitral valve. The systems, devices and methods may employ catheter based techniques and devices to plicate tissue and perform an annuloplasty.