Single Leaflet Stent-Valve Anchoring
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Solution Overview
Problem
Current cardiac stent-valves require complex and invasive procedures for implantation, often involving open heart surgery and risk of tissue damage due to the need for accurate connection of separate anchoring and support structures, which can lead to unreliable anchoring and paravalvular leakage.
Innovation Solution
A self-expandable stent-valve with a single leaflet attached along inclined fixation lines, which are partially perpendicular to the annular plane, providing a simple and efficient anchoring system that minimizes paravalvular leakage and ensures secure attachment to the cardiac annulus, while maintaining physiological blood flow patterns.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If separate anchoring member and support structure are used, then anchoring capability is improved, but device complexity increases and manufacturing precision requirements increase
Solution Approach 1:
The patent combines the anchoring member and support structure into a single integrated stent structure. The stent includes both anchoring elements (barbs, hooks, or form-fit portions) and support functions in one unified component, eliminating the need for separate members and their complex connections. This integration maintains reliable anchoring while significantly reducing device complexity and assembly requirements.
Solution Approach 2:
The stent is designed as a multi-functional component that simultaneously provides anchoring, support, and sealing functions. The same stent structure that anchors to the annulus also supports the valve leaflet and prevents paravalvular leakage, eliminating the need for specialized separate components for each function.
2Reliability
If separate anchoring member and support structure are used, then anchoring capability is improved, but manufacturing precision requirements increase
Solution Approach 1:
By integrating the anchoring and support functions into a single stent component manufactured as one piece, the patent eliminates the need for precise connection between separate members. The monolithic construction ensures consistent geometry and eliminates assembly tolerance accumulation, significantly reducing manufacturing precision requirements while maintaining anchoring reliability.
3Reliability
If complex anchoring system is used, then anchoring reliability is improved, but ease of operation deteriorates
Solution Approach 1:
The integrated stent design allows the entire anchoring and support system to be delivered and deployed as a single unit through catheter-based minimally invasive techniques. The unified structure simplifies the implantation procedure compared to coordinating multiple separate components, while maintaining reliable anchoring through the integrated design.
4Reliability
If traditional surgical approach is used, then valve replacement is achieved, but patient risk increases due to invasive procedure
Solution Approach 1:
The patent replaces the mechanical open-heart surgical approach with a catheter-based delivery system. The self-expandable stent is delivered percutaneously through a catheter and expands automatically upon deployment, eliminating the need for chest opening, heart arrest, and direct surgical manipulation, thereby significantly reducing patient risk while maintaining valve replacement efficacy.
Solution Approach 2:
The stent is designed in a compressed state for catheter delivery and then transitions to an expanded functional state at the implantation site. This parameter change from compressed to expanded configuration enables minimally invasive delivery while achieving the full functional dimensions needed for reliable anchoring and valve support.
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 stent-valve design ensures reliable anchoring, reduces the risk of paravalvular leakage, and maintains physiological blood flow, allowing for minimally invasive implantation and minimizing interference with surrounding tissues and blood flow.
Implementation Method 1
self-expandable stent-valve
Data Source
AI summary
A cardiac stent-valve (1), preferably a mitral stent-valve, comprising a stent component (2) and a valve component (3), wherein the stent component (2) comprises an inflow end (4) and an outflow end (5) and a wall between the inflow (4) and the outflow end (5), and wherein the valve component (3) is made of one single leaflet (6); the periphery of said single leaflet (6) being partially attached or attachable to the stent component (2) along at least fixation lines (7′, 7″), characterized in that said two fixation lines (7′) are at least partially inclined with respect to an annular plane of said valve perpendicular to a flow direction (A) through the stent-valve (1) and wherein the third fixation line (7″) runs parallel with respect to said plane.