Heart Valve Prosthesis with Localized Mesh Anchoring

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Solution Overview

Problem

Existing heart valve prostheses face issues with migration, obstruction of the ventricular outflow tract, difficult positioning, and a non-adapted shape, particularly in elderly patients, and require a larger access orifice, making them traumatic and less effective.

Innovation Solution

A heart valve prosthesis with a mesh structure only at the annular portion, featuring diamond-shaped meshes and U-shaped or V-shaped wire extensions for the atrial and ventricular portions, allowing radial contraction to a small diameter for minimally invasive introduction through an 18 mm orifice, and a 'crab claw' anchoring system for secure placement without obstructing the aortic valve.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If existing prostheses use a mesh structure throughout the entire frame, then structural strength is improved, but the catheter access diameter increases to 22 mm causing traumatic insertion

Engineering Contradiction:
Improvestructural strengthVSAvoidtraumatic insertion
Core Design Contradiction:
StrengthVSObject-affected harmful factors

Solution Approach 1:

The patent applies mesh structure only locally where needed (annular portion for anchoring) while using solid wire extensions (U-shaped or V-shaped) in other portions (atrial and ventricular portions). This local differentiation maintains structural strength at critical anchoring points while reducing overall profile to fit through an 18 mm catheter, eliminating the traumatic insertion issue.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The frame is segmented into three distinct portions: annular portion with mesh structure for anchoring, atrial portion with U-shaped extensions, and ventricular portion with V-shaped extensions. This segmentation allows each portion to have optimized properties - mesh where anchoring is needed, solid wire where flexibility and shape adaptation are prioritized - resolving the contradiction between strength and insertability.

Inventive Principle:
Principle #1Segmentation

2Ease of manufacture

If the prosthesis uses a uniform structure throughout, then manufacturing is simplified, but adaptation to the implantation site shape is reduced

Engineering Contradiction:
Improvemanufacturing simplicityVSAvoidadaptation to implantation site
Core Design Contradiction:
Ease of manufactureVSAdaptability or versatility

Solution Approach 1:

Different portions of the frame are given different structures: the annular portion uses diamond-shaped mesh for radial contraction and anchoring, while atrial and ventricular portions use U-shaped and V-shaped solid wire extensions respectively. This local quality differentiation enables each portion to adapt to its specific anatomical location while maintaining manufacturability through consistent fabrication processes.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The frame is divided into functionally distinct segments (annular, atrial, ventricular portions) with structures optimized for their specific functions. This segmentation allows the prosthesis to adapt perfectly to the implantation site geometry while using standardized manufacturing techniques for each segment type.

Inventive Principle:
Principle #1Segmentation

3Device complexity

If the prosthesis uses a larger access orifice of 22 mm, then device complexity is reduced, but the procedure becomes more traumatic for the cardiac wall

Engineering Contradiction:
Improvedevice simplicityVSAvoidcardiac wall trauma
Core Design Contradiction:
Device complexityVSObject-affected harmful factors

Solution Approach 1:

The frame uses flexible wire extensions (U-shaped in atrial portion, V-shaped in ventricular portion) that can be radially contracted to fit through an 18 mm catheter. These flexible structures maintain their expanded configuration after deployment, providing the needed structural support without requiring a larger access orifice, thus avoiding cardiac wall trauma.

Inventive Principle:
Principle #30Flexible shells and thin films

Solution Approach 2:

The prosthesis design allows parameter changes in the contraction ratio - the frame can be compressed to 18 mm for insertion and then expands to its functional size after deployment. This parameter transformation enables passage through a smaller catheter while maintaining adequate device dimensions for proper function, reducing cardiac wall trauma.

Inventive Principle:
Principle #35Parameter changes

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

Enables easy, minimally traumatic implantation with low risk of migration and perfect adaptation to the heart's anatomy, facilitating precise placement and function without interfering with adjacent structures.

Implementation Method 1

The tubular frame, frequently called a 'stent,' has a mesh structure and includes an atrial portion, designed to be positioned in the atrium of the heart, a ventricular portion, designed to be positioned in the ventricle of the heart, and an annular portion, designed to be positioned in the native valve annulus located between these atrial and ventricular portions. The frame can be self-expanding (made of a shape-memory material, for example)

Methodology Applied
Scientific EffectShape memory: Shape Memory Alloy

Data Source

PatentEP3373859B1Mitral or tricuspid heart valve prosthesis
Publication Date: 2023.07.05 VALMY HLDG
  • EP3373859B1 patent drawingFigure 1~4
  • EP3373859B1 patent drawingFigure 5

AI summary

The invention relates to a mitral or tricuspid heart valve prosthesis (1) which comprises an expansible tubular frame (2) and a prosthetic valve (3) mounted on said frame. The frame comprises an atrial portion (2a), a ventricular portion (2v) and an annular portion (2i) located between said atrial and ventricular portions, wherein: the atrial portion (2a) is made up of three or four metal-wire extensions (4), regularly distributed on the circumference of said atrial portion (2a) and projecting from said annular portion (2i), each extension (4) being made up of a single upside-down U-shaped or V-shaped wire and the various extensions (4) being substantially part of an imaginary truncated sphere placed above said annular portion (2i); said annular portion (2i) is made up of diamond meshes which comprise anchoring points (5); and said ventricular portion (2v) is made up of three or four extensions (6) equivalent to the extensions (4), substantially contained inside an imaginary ovoid shape placed under said annular portion (2i).