Mitral Valve Replacement With D-Shaped Support And Flexible Retainer

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Solution Overview

Problem

Current prosthetic heart valve devices face challenges in effectively replacing the mitral valve due to its non-circular, asymmetric shape, leading to leaks and instability, and existing methods are invasive, risky, and dependent on surgical skill.

Innovation Solution

A prosthetic heart valve device with a flexible valve support and expandable retainer that conforms to the mitral valve's shape, mechanically isolating it from distorting forces, and includes arms to engage leaflets and subannular tissue for secure anchoring, allowing for percutaneous deployment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If a cylindrical valve prosthesis is used for mitral valve replacement, then the procedure is simpler, but gaps are left in commissural regions causing perivalvular leaks

Engineering Contradiction:
Improvesimplicity of procedureVSAvoidsealing performance
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

The valve support is designed with an asymmetric D-shaped cross-section that matches the natural anatomy of the mitral valve annulus. This asymmetric configuration allows the prosthesis to conform to the non-circular mitral valve geometry, eliminating gaps in commissural regions and preventing perivalvular leaks while maintaining procedural simplicity

Inventive Principle:
Principle #4Asymmetry

2Stability of the object's composition

If a direct structural connection is made between the device structure contacting the annulus and the support structure, then the device is more stable, but distorting forces cause hoop stress in the stent portion

Engineering Contradiction:
Improvedevice stabilityVSAvoidhoop stress in stent
Core Design Contradiction:
Stability of the object's compositionVSStress or pressure

Solution Approach 1:

The device is divided into functionally independent segments: a deformable retainer that contacts the annulus and absorbs distorting forces, and a rigid valve support that maintains structural integrity. The retainer is coupled to the valve support at the upstream end, creating a mechanical isolation that prevents transmission of hoop stress to the stent portion while maintaining device stability

Inventive Principle:
Principle #1Segmentation

3Device complexity

If the same stent posts support both the prosthetic valve and contact subannular tissue, then the device structure is simpler, but systolic and diastolic pressures cause compression and distortion of the cylindrical structure

Engineering Contradiction:
Improvestructural simplicityVSAvoidcylindrical structure integrity
Core Design Contradiction:
Device complexityVSStrength

Solution Approach 1:

The device separates the support function from the anchoring function. The valve support provides structural support for the prosthetic valve, while the separate deformable retainer anchors to subannular tissue. This segmentation protects the cylindrical valve support structure from compression and distortion by systolic and diastolic pressures

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The deformable retainer acts as an intermediary between the annulus/subannular tissue and the valve support. It absorbs and isolates distorting forces from systolic and diastolic pressures, preventing these forces from being transmitted to and deforming the rigid cylindrical valve support structure

Inventive Principle:
Principle #24Intermediary (Mediator)

4Loss of time

If percutaneous approach is used for mitral valve replacement, then patient recovery is faster, but the non-circular mitral annulus geometry makes device conformability difficult

Engineering Contradiction:
Improverecovery timeVSAvoiddevice conformability to annulus shape
Core Design Contradiction:
Loss of timeVSAdaptability or versatility

Solution Approach 1:

The valve support is designed with an asymmetric D-shaped cross-section that matches the natural anatomy of the mitral valve annulus. This asymmetric configuration enables the device to conform to the non-circular mitral valve geometry through percutaneous access, achieving both fast recovery and proper anatomical fit

Inventive Principle:
Principle #4Asymmetry

Solution Approach 2:

The retainer is designed to be deformable, allowing it to adapt dynamically to the irregular shape of the mitral annulus during deployment. This dynamic adaptability enables proper conformability to the non-circular anatomy while maintaining the benefits of percutaneous access and quick recovery

Inventive Principle:
Principle #15Dynamics

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

The device provides a secure, less-invasive mitral valve replacement with faster recovery, maintaining structural integrity and adaptability to the heart's dynamic conditions, reducing leaks and risks associated with traditional methods.

Implementation Method 1

an expandable retainer (110) configured to engage tissue on or downstream of an annulus of the heart valve. The valve support (120) is mechanically isolated from the retainer (110) such that a cross-sectional shape of the valve support (120) remains sufficiently stable when the retainer (110) is deformed in a non-circular shape by engagement with the tissue

Methodology Applied
Scientific EffectElastic deformation: Elasticity

Implementation Method 2

Devices are provided herein for percutaneous replacement of native heart valves, such as mitral valves

Methodology Applied
Scientific EffectFluid flow:

Data Source

PatentEP4252714B1Device for heart valve replacement
Publication Date: 2025.08.13 TWELVE INC
  • EP4252714B1 patent drawingFigure 1~2
  • EP4252714B1 patent drawingFigure 3~4A
  • EP4252714B1 patent drawingFigure 4B~5B

AI summary

A prosthetic heart valve device (100) for percutaneous replacement of a native heart valve includes an expandable retainer (110) at least partially surrounding and coupled to an inner valve support (120). The device can further include a prosthetic valve (130) coupled to the valve support. The retainer forms a donut-shaped flange (190) having an arcuate outer surface (142) for engaging tissue and an inner lumen defining a passage for blood to flow through the valve support. The retainer can include a plurality of circumferentially positioned, resiliency deformable and flexible ribs (114) which are coupled at their downstream ends 116 to the valve support 120. The flexible ribs, in one embodiment, can have a general C-shape configuration with the tips (117) of the flexible ribs and an opening (119) of the C-shape configuration oriented toward a longitudinal axis (101) of the device.