Deflectable Guidewire Introducer for Transseptal Mitral Valve Access

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Solution Overview

Problem

Existing transcatheter procedures for implanting heart prostheses, particularly for atrio-ventricular valves like the mitral valve, face challenges due to the complex anatomical configuration and risk of damaging the heart apex, such as bleeding and aneurisms, and lack reliability and safety.

Innovation Solution

A guidewire introducer device and implantation method using transseptal access, allowing guidewires to be deployed around the mitral valve without damaging the left ventricle, utilizing a system of catheters with distal deflection systems and radiopaque markers for precise positioning, and a device for connecting the prosthesis components.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If transapical access is used for implanting heart prosthesis, then the procedure can be performed with beating heart and limited surgical practices, but it risks damaging the heart apex causing bleeding and aneurisms

Engineering Contradiction:

Improveminimally invasive surgeryVSAvoidheart apex damage

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

Instead of accessing the mitral valve from the ventricular side (transapical approach), the invention uses transseptal access from the atrial side. This inverted approach route avoids the heart apex and ventricular wall, eliminating the risk of apex damage while maintaining the benefits of minimally invasive transcatheter procedure

Inventive Principle:

Principle #13The other way round (Inversion)

Solution Approach 2:

The invention introduces an intermediary structure (the septum) as the access point. By puncturing the septum between atria rather than the ventricular wall, the procedure uses a safer intermediary pathway that avoids direct contact with vulnerable heart apex structures

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If conventional open-heart surgery is used for valve replacement, then reliable valve implantation can be achieved, but it requires heart arrest and extracorporeal circulation with high invasiveness

Engineering Contradiction:

Improvevalve implantation reliabilityVSAvoidinvasive procedure risks

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The invention replaces the mechanical open-heart surgical system (requiring sternotomy, heart arrest, and extracorporeal circulation) with a transcatheter-based system. The guidewire introducer device delivers the prosthesis through catheters via transseptal access, substituting invasive mechanical surgery with a less invasive endovascular approach while maintaining implantation reliability

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

3Object-affected harmful factors

If transseptal access with guidewire introducer device is used, then heart apex damage is avoided, but the device complexity increases with multiple catheters and deflection systems

Engineering Contradiction:

Improveheart apex damageVSAvoidcatheter system complexity

Core Design Contradiction:

Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The invention employs a nested catheter configuration where the second catheter is inserted inside the first catheter, and the third catheter is inserted inside the first catheter as well. This nested arrangement allows multiple functions (guidewire delivery, deflection control, capture) to be integrated within a compact structure, reducing overall device complexity while maintaining the safety benefits of transseptal access

Inventive Principle:

Principle #7Nested doll (Nesting)

Data Source

PatentUS12569341B2Device for arranging guidewires around a heart valve

Publication Date: 2026.03.10 INNOVHEART SRL

AI summary

A guide wire introduction device for positioning at least one guide wire around a heart valve. The device includes a first catheter provided with a distal deflection system, a second catheter inserted inside the first catheter, at least one lumen capable of causing a guide wire to slide therein and provided with a distal deflection system for deflecting the end thereof through an angle greater than 90°, and a third catheter inserted inside the first catheter. The third catheter has a guide wire capturing device therein and is provided with a distal deflection system.