Mitral Prosthetic Valve Anchoring for Accurate Catheter Placement

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Solution Overview

Problem

There is a need for minimally invasive techniques to replace the mitral valve, particularly for elderly and frail patients, with enhanced ease of implantation and reduced risk of misplacement due to operator error or biological variability, and the ability to move synchronously with the native valve annulus.

Innovation Solution

A prosthetic valve design featuring an atrial cap and ventricular anchors that secure the valve within the native valve annulus, using atrial anchors to apply pressure on the atrial surface and ventricular anchors to engage the ventricular side, allowing synchronous movement with the native annulus, and optionally incorporating a radially compressible main body for delivery and self-expansion.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If a prosthetic valve is implanted using a catheter-based approach, then the invasiveness of the procedure is reduced, but the risk of misplacement due to operator error or biological variability increases

Engineering Contradiction:
ImproveinvasivenessVSAvoidplacement accuracy
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The prosthetic valve is designed with self-aligning features including an atrial cap that engages with the atrial annulus and ventricular anchors that engage with the ventricular side of the native valve. These features enable the valve to self-position and self-align within the valve annulus without requiring precise manual alignment by the operator, thereby maintaining low invasiveness while improving placement accuracy.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The prosthetic valve incorporates a radially compressible main body that can be compressed to a smaller diameter for delivery through a catheter and then expanded at the implantation site. This parameter change allows the valve to be delivered minimally invasively and then deployed to its functional size with proper engagement of the atrial cap and ventricular anchors, ensuring accurate placement.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If a prosthetic valve is designed to be securely anchored in the valve annulus, then the risk of perivalvular leakage is reduced, but the complexity of the device structure increases

Engineering Contradiction:
Improvesealing performanceVSAvoiddevice structure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The prosthetic valve is segmented into distinct functional components: a main body, an atrial cap extending from the atrial end, and multiple ventricular anchors extending from the ventricular end. This segmentation allows each component to perform its specific function - the atrial cap seals the atrial side, the main body provides the valve mechanism, and the ventricular anchors secure the device - thereby achieving reliable sealing without excessive overall complexity.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The atrial cap and ventricular anchors are integrated with the main body of the prosthetic valve to form a unified device. The atrial cap is connected to the atrial end of the main body, and the ventricular anchors are connected to the ventricular end, creating a combined structure that provides both sealing and anchoring functions while maintaining structural coherence and avoiding excessive complexity.

Inventive Principle:
Principle #5Merging (Combining)

3Duration of action of stationary object

If a prosthetic valve is designed to move synchronously with the native valve annulus, then the durability of the implant is improved, but the device must accommodate physiological movement which increases design complexity

Engineering Contradiction:
Improveimplant durabilityVSAvoiddesign complexity
Core Design Contradiction:
Duration of action of stationary objectVSDevice complexity

Solution Approach 1:

The prosthetic valve is designed with dynamic characteristics that allow it to move synchronously with the native valve annulus during cardiac cycling. The atrial cap and ventricular anchors are configured to accommodate the physiological movement and expansion of the annulus, enabling the device to adapt to changing geometric conditions without compromising durability or requiring overly complex design mechanisms.

Inventive Principle:
Principle #15Dynamics

Data Source

PatentEP4445873B1Prosthetic valve for replacing a mitral valve
Publication Date: 2025.11.19 EDWARDS LIFESCIENCES CORP
  • EP4445873B1 patent drawingFigure 1A~2
  • EP4445873B1 patent drawingFigure 3A~3C
  • EP4445873B1 patent drawingFigure 4

AI summary

Embodiments of a prosthetic heart valve comprise an annular main body, an atrial cap extending radially outwardly from the atrial end of the main body, and a plurality of ventricular anchors extending outwardly from the ventricular end of the main body. Each ventricular anchor can have a proximal end portion connected to the ventricular end, an intermediate portion extending away from the atrial end and then back toward the atrial so as to define a first bend, and a free distal end portion that extends from the intermediate portion. The distal end portion can comprise a first section, a second section, and a second bend between the first and second sections, the first section extending from the intermediate portion in a direction toward the atrial end and radially away from the main body.