Transapical Mitral Valve Stent Segmentation Anchoring

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Solution Overview

Problem

Current transcatheter mitral valve replacement devices face challenges in accurately fitting the irregular contour of the mitral valve annulus and providing sufficient radial support without risking collapse of the aortic outflow tract.

Innovation Solution

The transapical implantable mitral valve device features an outer valve stent with an anchoring unit and a cavity formed between the outer and inner valve stents, allowing for firm anchoring and radial support while maintaining the ideal contour for the mitral valve.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Device complexity

If a single stent structure is used to replace the mitral valve, then the device complexity is reduced, but the ability to fit the irregular contour of the mitral valve annulus and provide sufficient radial support deteriorates

Engineering Contradiction:
Improvestent structureVSAvoidfitting accuracy
Core Design Contradiction:
Device complexityVSManufacturing precision

Solution Approach 1:

The stent is divided into two independent components: an inner stent and an outer stent. The inner stent provides radial support and anchors the valve leaflets, while the outer stent conforms to the irregular mitral valve annulus contour. This segmentation allows each stent to be optimized for its specific function, improving overall fitting accuracy without excessive complexity.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The inner stent is nested within the outer stent, forming a dual-layer structure. The inner stent is positioned inside the outer stent, with both stents working together to replace the mitral valve. This nested configuration allows the device to accommodate the irregular annulus shape while maintaining structural integrity and radial support.

Inventive Principle:
Principle #7Nested doll (Nesting)

2Reliability

If radial support force is increased to ensure stable anchoring, then the anchoring reliability is improved, but the risk of aortic outflow tract collapse increases

Engineering Contradiction:
Improveanchoring reliabilityVSAvoidaortic outflow tract collapse
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The outer stent is designed with varying radial stiffness along its structure, with higher stiffness at the mitral valve annulus for stable anchoring and lower stiffness at the aortic outflow tract region to prevent collapse. This localized variation in mechanical properties allows the device to provide strong anchoring where needed while protecting vulnerable structures.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The outer stent incorporates flexible segments that can adapt to the irregular mitral valve annulus contour while providing sufficient radial support. The flexibility allows the stent to conform to the anatomy without exerting excessive force that could collapse the aortic outflow tract, achieving a balance between anchoring reliability and tissue protection.

Inventive Principle:
Principle #30Flexible shells and thin films

3Ease of manufacture

If the stent structure is simplified for easier manufacture, then the ease of manufacture is improved, but the ability to prevent perivalvular leakage deteriorates

Engineering Contradiction:
Improvestent fabricationVSAvoidsealing performance
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

The sealing function is segmented and assigned to the outer stent, which is specifically designed to conform to the irregular mitral valve annulus contour. The outer stent includes sealing elements that prevent perivalvular leakage, while the inner stent maintains a simpler structure focused on radial support and valve leaflet anchoring. This segmentation allows the sealing complex structure to be localized where needed.

Inventive Principle:
Principle #1Segmentation

Data Source

PatentUS12318282B2Transapical implantable mitral valve device
Publication Date: 2025.06.03 SINO MEDICAL SCIENCES TECHNOLOGY INC
  • US12318282B2 patent drawing
  • US12318282B2 patent drawing
  • US12318282B2 patent drawing

AI summary

The present invention provides a transapical implantable mitral valve device, which includes an outer valve stent comprising an outer valve stent body that is composed of a plurality of first structure units arranged in the circumferential direction and an anchoring unit that is disposed on the outer valve stent body for anchoring the mitral valve device in a human body, at least one of an inner surface and an outer surface of the outer valve stent body being covered with an outer skirt; an inner valve stent disposed inside the outer valve stent and interconnected with the outer valve stent, a cavity being formed between the outer valve stent and the inner valve stent; and a valve leaflet structure disposed in the inner valve stent to form a prosthetic valve.