Segmented Stent Frame Design for Atrioventricular Valve Anchoring
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Solution Overview
Problem
Current medical implants and stents for treating tricuspid and mitral valve leakage or regurgitation are inadequate in minimizing recovery time and effectively addressing hemodynamic deterioration and heart failure associated with atrioventricular regurgitation.
Innovation Solution
A stent for surgical valves with a unique frame design, comprising interconnected sections that expand to fit anatomically at the atrial junction of the Superior Vena Cava and Inferior Vena Cava, providing an interference fit and additional anchoring features to prevent dislodgment and enhance heart function, allowing for minimally invasive deployment and reduced rehabilitation time.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional stents are used for treating atrioventricular regurgitation, then the treatment can be provided, but the recovery time is extended and hemodynamic deterioration is not effectively addressed
Solution Approach 1:
The stent is divided into three distinct sections (proximal, middle, distal) with different geometries and functions. The proximal section has a smaller diameter for atrial engagement, the middle section has a larger diameter for venous anchoring, and the distal section tapers for deep vein engagement. This segmentation allows simultaneous achievement of secure anchoring (improving reliability) and minimally invasive delivery (reducing recovery time).
Solution Approach 2:
The stent transitions from a two-dimensional compressed state during delivery to a three-dimensional expanded state at the implantation site. The non-circular cross-section in the compressed state allows for compact delivery through catheters, while the expanded state provides sufficient radial force for secure anchoring in the venous anatomy, effectively treating regurgitation while minimizing invasion.
2Ease of manufacture
If the stent is designed with a uniform diameter, then manufacturing is simplified, but the stent cannot provide effective anchoring in the complex venous anatomy
Solution Approach 1:
Different sections of the stent are designed with different diameters and geometries optimized for their specific functions. The proximal section has a smaller diameter for atrial valve engagement, the middle section has a larger diameter for venous anchoring and interference fit, and the distal section tapers for deep vein engagement. This local differentiation of properties ensures reliable anchoring in complex venous anatomy while remaining manufacturable through standard stent fabrication techniques.
3Device complexity
If the stent uses a circular cross-section, then the design is simpler, but it cannot effectively accommodate the non-circular valve annulus geometry
Solution Approach 1:
The stent is designed with a non-circular cross-section that matches the anatomical geometry of the valve annulus. This asymmetric shape allows the stent to conform to the non-circular opening between the atrium and ventricle, ensuring complete leaflet apposition and effective prevention of regurgitation. The asymmetric design, while slightly more complex than a circular design, remains manufacturable and provides superior functional performance.
4Ease of manufacture
If the stent is made with a single material, then manufacturing is easier, but it cannot optimize both flexibility for delivery and strength for anchoring
Solution Approach 1:
The stent is constructed from composite materials that combine the advantages of different material properties. The frame structure uses a superelastic alloy (such as Nitinol) that provides both flexibility for compression and delivery through catheters, and sufficient radial strength for secure anchoring in the venous anatomy. The composite construction may include different alloy compositions or coatings in different sections to optimize local mechanical properties for both delivery and long-term anchoring functions.
Data Source
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AI summary
The present invention relates to a stent for a surgical valve for the heterotopic treatment of atrioventricular regurgitation that is expandable from an un-deployed state into a deployed state, and that comprises a frame composed of a plurality of first arms forming three interconnected sections, a proximal section, a distal section and a middle section disposed between the proximal section and the distal section, wherein, in the deployed state, a maximum outer diameter of the middle section is larger than a maximum outer diameter of the proximal section and a length of the proximal section corresponds to 35 to 70% of the length of the middle section, with the proximal section having an at least substantially equal outer diameter over its length or an outer diameter that converges towards the middle section at least substantially linearly over its length and wherein, in the deployed state, the plurality of first arms is outwardly directed in the distal section of the frame.