Heart Valve Prosthesis with Varying Strut Thickness

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Solution Overview

Problem

Existing heart valve prostheses struggle to adapt correctly to the anatomical environment of the mitral valve annulus, particularly in terms of radial geometry, which is D-shaped, leading to suboptimal functioning and durability.

Innovation Solution

A heart valve prosthesis secured to an expandable stent framework with varying strut thickness in the peripheral direction, allowing the framework to adapt to a D-shaped cross-sectional contour matching the mitral valve annulus, achieved by thinner struts at the fibrous trigones and a modified cell structure for deformation, enabling a secure and anatomically correct fit.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If a uniform stent framework is used, then manufacturing is simpler, but the prosthesis cannot adapt to the D-shaped mitral valve annulus geometry

Engineering Contradiction:
Improvestent framework manufacturingVSAvoidadaptation to mitral valve annulus geometry
Core Design Contradiction:
Ease of manufactureVSAdaptability or versatility

Solution Approach 1:

The stent framework employs struts with varying thicknesses along its peripheral circumference, creating local quality differences. Specifically, certain struts are designed with greater thickness than others to provide enhanced structural support in regions requiring higher rigidity, while thinner struts are used in areas needing flexibility for deformation. This non-uniform strut thickness distribution enables the framework to adapt to the D-shaped mitral valve annulus geometry while maintaining manufacturability through controlled variation rather than complete complexity.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The invention introduces asymmetry into the stent framework design by deliberately creating an asymmetric distribution of strut thicknesses around the peripheral direction. This asymmetric configuration allows the framework to transform from a circular shape in its compressed state to a D-shaped contour when expanded and implanted, matching the natural anatomy of the mitral valve annulus. The asymmetric design is achieved through selective thickening of specific struts while keeping others thinner, enabling geometric adaptation without requiring completely different manufacturing processes.

Inventive Principle:
Principle #4Asymmetry

2Strength

If the stent framework is made rigid for durability, then it provides stronger support, but it cannot deform to match the anatomical geometry

Engineering Contradiction:
Improvestent framework supportVSAvoiddeformation capability
Core Design Contradiction:
StrengthVSAdaptability or versatility

Solution Approach 1:

The stent framework achieves the balance between strength and deformability through local quality variation in strut thickness. Thicker struts are positioned in regions requiring high structural support and rigidity to maintain durability, while thinner struts are placed in areas that need to deform to match the anatomical geometry of the mitral valve annulus. This spatially differentiated design allows different portions of the framework to exhibit different mechanical properties, simultaneously satisfying both strength and adaptability requirements.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The invention implements dynamic characteristics in the stent framework by designing it to transition between different structural states. In its compressed delivery state, the framework maintains a rigid circular shape for easy catheter-based delivery. Upon deployment, it transforms into an expanded D-shaped configuration that conforms to the mitral valve annulus. The varying strut thicknesses enable this dynamic transformation, allowing the framework to be rigid when needed for support and flexible when needed for geometric adaptation.

Inventive Principle:
Principle #15Dynamics

3Adaptability or versatility

If the struts are made thinner to achieve D-shaped contour, then adaptability improves, but structural strength decreases

Engineering Contradiction:
Improveadaptation to D-shaped contourVSAvoidstrut structural strength
Core Design Contradiction:
Adaptability or versatilityVSStrength

Solution Approach 1:

The invention resolves the strength-adaptability trade-off by applying local quality principles to strut thickness. Instead of uniformly thinning all struts to achieve the D-shaped contour, the design selectively thins only those struts located in regions where flexibility and deformation are prioritized. Struts in regions requiring high structural support maintain greater thickness. This localized differentiation allows the framework to achieve the desired D-shaped geometry while preserving structural strength in critical areas.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The asymmetric distribution of strut thicknesses enables the framework to achieve D-shaped contour adaptation without uniformly compromising structural strength. By strategically placing thicker struts in specific asymmetric positions around the framework perimeter, the design creates regions of high strength where needed while allowing other regions to be thinner for geometric conformity. This asymmetric thickening strategy ensures that adaptability to the D-shaped contour is achieved without sacrificing overall structural integrity.

Inventive Principle:
Principle #4Asymmetry

Data Source

PatentUS10682226B2Heart valve prosthesis
Publication Date: 2020.06.16 BIOTRONIK AG
  • US10682226B2 patent drawing
  • US10682226B2 patent drawing
  • US10682226B2 patent drawing

AI summary

A heart valve prosthesis (1), including: a stent framework (2), which can be transferred from a collapsed state into an expanded state, in which the stent framework (2) extends along an axis (A′), wherein the stent framework (2) has a plurality of struts (20, 24), which form a plurality of cells (21a, 21b, 25) connected to one another; and a heart valve (3), which is fixed to the stent framework (2). In accordance with the invention, the thickness (d′) of the struts varies in the peripheral direction (U) of the expanded stent framework (2).