Prosthetic Valve Radial Anchor Elements Mitral Annulus
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Solution Overview
Problem
The existing valve prostheses for replacing the mitral valve are not suitable for stable and orthotropic anchoring due to the flexibility of the mitral valve annulus, which lacks sufficient support for radial expansion force-based anchoring.
Innovation Solution
A valve prosthesis with an annulus and radially extending anchor elements that clamp tissue between themselves and the outer wall, providing axial support and preventing displacement, while avoiding frictional engagement with heart tissue, and featuring adjustable anchor lengths for anatomical adaptation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a valve prosthesis is anchored by radial expansion force of a stent, then anchoring is achieved, but the mitral valve annulus offers insufficient support due to its flexibility
Solution Approach 1:
The stent structure is segmented into multiple anchor elements that extend radially outward from the annular body. These discrete anchor elements (at least three, preferably four or more) are distributed around the circumference to engage with the annulus at multiple points, converting the single radial expansion force into multiple localized anchoring points that collectively provide stable support despite the flexible annulus.
Solution Approach 2:
The anchor elements are designed with specific local properties: they extend radially outward to engage the annulus, have axial lengths that extend over at least half the axial length of the ring body, and are bent in the axial direction at the end of the annular body. These localized structural modifications create regions of enhanced engagement and support where needed most.
2Reliability
If anchor elements extend radially outward to engage tissue, then stable positioning is achieved, but frictional effect with heart tissue may occur
Solution Approach 1:
The anchor elements are rounded off at their free-standing axial ends, for example by merging into a ring. This curvature modification eliminates sharp edges that would create high stress concentrations and frictional effects with the heart tissue. The rounded geometry allows smoother interaction with the annulus and valve leaflets, reducing tissue damage while maintaining anchoring stability.
3Ease of operation
If the annular body is compressed for catheter introduction, then minimally invasive implantation is enabled, but the structure must be highly compressible
Solution Approach 1:
The annular body and anchor elements are constructed from flexible materials that can be compressed to a small profile for catheter introduction and then expand to their functional shape upon deployment. This flexibility allows the complex multi-element structure to be delivered through minimally invasive catheter-based approaches while maintaining the structural integrity needed for stable anchoring after expansion.
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 stable and orthotropic positioning and anchoring of the valve prosthesis, ensuring secure sealing during systole without significant radial expansion, allowing for minimally invasive catheter-based implantation and unhindered blood flow.
Implementation Method 1
This small radial spacing of the anchor elements from the outer wall of the ring body is dimensioned such that the anchor elements clamp tissue of valve leaflets and chordae in particular between themselves and the outer wall of the ring body.
Implementation Method 2
The stent, which can be balloon-expanded or self-expanded, for example, develops a radial expansion force in the released state, which causes or at least promotes anchoring of the replacement valve prosthesis.
Data Source
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AI summary
A prosthetic valve for replacing an atrioventricular heart valve comprises an annular body (2) on which valvular cusps are fastened and which is adapted to be inserted into a valve annulus (18) of the heart (20). The annular body has a plurality of anchor elements which are connected thereto on the ventricle side and optionally other anchor elements which are connected to the annular body on the atrium side. Said anchor elements extend radially outside the annular body and substantially parallel to its outer wall.