Mitral Valve Prosthesis Assembly via Transseptal Catheter Access
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Solution Overview
Problem
Current transcatheter procedures for implanting heart valve prostheses, particularly for the mitral valve, face challenges due to the complex anatomical configuration and risk of damaging the heart's apex, making them unreliable and unsafe for patients with advanced age or concomitant pathologies.
Innovation Solution
A guidewire introducer device and transcatheter implantation procedure using transseptal access, allowing guidewires to be deployed around the mitral valve without damaging the left ventricle, and a device for assembling the prosthesis using catheters with distal deflection systems and guidewire capturing mechanisms to facilitate safe and reliable implantation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If transapical access is used for mitral valve prosthesis implantation, then the procedure can be performed with reduced invasiveness compared to open-heart surgery, but there is a risk of damaging the heart's apex and the procedure becomes unsafe for patients with advanced age or concomitant pathologies
Solution Approach 1:
The patent inverts the traditional transapical approach by using transseptal access instead. Rather than approaching the mitral valve from the apex of the left ventricle, the catheter is introduced through the femoral vein, navigated to the right atrium, and then crossed into the left atrium through the interatrial septum. This reverse routing eliminates apex damage while maintaining transcatheter benefits.
Solution Approach 2:
The patent uses the interatrial septum as an intermediary structure to gain access to the left atrium. By puncturing the septum between the right and left atria, the procedure creates a safe passage route that avoids direct contact with the left ventricular apex, thus eliminating the risk of apex damage while still enabling mitral valve intervention.
2Ease of operation
If the heart apex is punctured to access the mitral valve, then transcatheter implantation can be achieved, but damage to the left ventricle occurs making the procedure unreliable
Solution Approach 1:
The interatrial septum serves as an intermediary access point that allows catheter entry into the left atrium without puncturing the left ventricle. This intermediate route through the septum and right atrium provides safe access to the mitral valve while avoiding direct damage to the left ventricular tissue.
Solution Approach 2:
Instead of the conventional transapical route that punctures the left ventricle, the patent inverts the approach by accessing the mitral valve from the left atrium side through the interatrial septum. This reversed routing eliminates ventricular damage while maintaining procedural accessibility.
3Ease of operation
If open-heart surgery is performed for valve replacement, then direct access to the malfunctioning valve is achieved, but the procedure requires temporary arrest of the heart and creation of extracorporeal artificial blood circulation increasing invasiveness and duration
Solution Approach 1:
The patent uses catheters and the interatrial septum as intermediaries to achieve valve access without open-heart surgery. The catheter-based system allows navigation through the vascular system and septal puncture to reach the mitral valve, eliminating the need for chest opening, heart arrest, and extracorporeal circulation while maintaining adequate access for prosthesis deployment.
Data Source
AI summary
A device for implanting a heart prosthesis including a central body, a containment portion having one or more sub-components, and a release device for the central body capable of being inserted into a catheter. A device for assisting the connection operation between the central body and the sub-components of the containment portion includes an assembly of catheters, of which there are at least two catheters for each sub-component of the containment portion, the catheters being joined to each other over a portion thereof and having at least one free end for each catheter.