Mitral Valve Stent Anchoring via Winglets and Truncated Cone
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Solution Overview
Problem
Current catheter-guided techniques for replacing mitral heart valves are hindered by the complexity of the mitral valve apparatus, leading to difficulties in precise delivery, deployment, and anchoring, as well as issues with peripheral valvular leaks, which have resulted in incomplete repairs and high mortality rates among patients with severe mitral regurgitation.
Innovation Solution
A bioprosthetic heart valve assembly featuring a stent with a truncated cone geometry and a valvular mechanism, designed to minimize intrusion into the atrium and securely anchor onto the dilated mitral annulus, utilizing self-expanding winglets and anchors to prevent migration and leaks, while maintaining optimal blood flow and pressure properties.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If catheter-guided techniques are used to deliver valved stent, then invasiveness is reduced and mortality risk is lowered, but delivery precision and deployment accuracy become difficult to achieve
Solution Approach 1:
The delivery system is divided into multiple functional segments: a collapsible valved stent, an expandable cage structure, and a separate delivery catheter. This segmentation allows each component to be optimized independently for its specific function while maintaining overall system precision during catheter-guided delivery.
Solution Approach 2:
The valved stent is nested within an expandable cage structure, which in turn is delivered through a catheter. This nested configuration enables the entire assembly to be compressed to a small profile for minimally invasive delivery, then sequentially deployed to achieve precise positioning and accurate deployment at the target mitral valve site.
2Device complexity
If traditional anchoring methods are used, then device simplicity is maintained, but anchoring security and migration prevention are insufficient
Solution Approach 1:
The anchoring system transitions from a static simple structure to a dynamic multi-component system where the expandable cage and deployable anchors work together. The cage expands radially to engage the annulus, while individual anchors can be deployed sequentially to lock the device in place, providing adaptive securing that responds to anatomical variations.
Solution Approach 2:
The expandable cage structure utilizes the natural radial expansion force and anatomical engagement with the mitral annulus to achieve self-anchoring. The geometry of the cage and its interaction with the annular tissue provide inherent mechanical interlocking that secures the device without requiring additional active anchoring mechanisms.
3Ease of manufacture
If simple valved stent design is used, then manufacturing ease is maintained, but peripheral valve leaks cannot be prevented
Solution Approach 1:
The valve assembly combines the valved stent with an expandable cage structure made of complementary materials and geometries. The cage acts as a sealing framework that works in conjunction with the stent's valve leaflets, creating a composite structure that addresses peripheral gaps and prevents leaks while maintaining manufacturing feasibility through modular construction.
Solution Approach 2:
The solution addresses peripheral leaks by adding a radial dimension to the sealing mechanism. The expandable cage extends outward from the stent in the radial direction, filling gaps between the stent and annulus that cannot be addressed by axial design modifications alone, thereby preventing peripheral valve leaks.
4Ease of operation
If stent expands fully at target site, then valve function is optimized, but device migration and positional control become difficult
Solution Approach 1:
The expandable cage is deployed in advance of the valved stent, establishing a fixed positional framework and anchoring structure first. This preliminary action creates a stable reference structure that prevents migration and maintains positional control, allowing the valved stent to then expand fully to optimize valve function without compromising placement accuracy.
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 solution enables precise and secure placement of the valved stent, reducing the risk of migration and peripheral leaks, thereby improving the functional outcome of mitral valve replacement and reducing mortality associated with mitral regurgitation.
Implementation Method 1
a shape memory metal mounting frame, to which the biological membrane is attached
Data Source
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AI summary
The present invention is a replacement mitral valve suitable for catheter-based deployment. The replacement mitral valve has structure and dimensions that are uniquely suited to engage the annulus surrounding the native mitral valve and to restore normal function to a diseased valve. The invention describes the structures and functions of a replacement mitral valve and methods that are adapted for minimally invasive, catheter-based deployment of the valve.