Mitral Valve Prosthesis Cuff Expansion Sealing
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Solution Overview
Problem
Current percutaneous valved stent designs for mitral valve replacement lack the necessary design characteristics for successful implantation, stability, and long-term functionality, such as compatibility with delivery modalities, anchoring to the valvular ring, sealing the anchor point, and normal functioning post-implantation.
Innovation Solution
The development of a mitral valve prosthesis comprising a self-expanding stent with an outer and interior surface, upper and lower anchoring flanges, and a cuff made of absorbent material that expands to adhere to the implantation site, ensuring secure positioning and sealing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a percutaneous valved stent is designed for mitral valve replacement, then it must be compatible with delivery modalities and function normally post-implantation, but existing designs fail to achieve successful implantation and long-term functionality
Solution Approach 1:
The stent is divided into distinct functional segments: an upper anchoring flange, a lower anchoring flange, and a middle region with a valve. Each segment performs a specific function - the flanges provide anchoring to the valvular ring while the middle region houses the valve mechanism, enabling reliable implantation and long-term functionality.
Solution Approach 2:
The stent is designed with pre-formed anchoring flanges that are positioned to engage with the valvular ring before the valve mechanism is activated. This preliminary anchoring ensures stable implantation and prevents displacement during subsequent valve function and healing.
2Strength
If the stent uses absorbent material that expands to adhere to the implantation site, then secure anchoring is achieved, but the adhering process is delayed to permit positioning
Solution Approach 1:
The stent is positioned and secured mechanically by the rigid framework and anchoring flanges before the absorbent material fully expands. This preliminary mechanical anchoring allows for positioning adjustments while the expansion process occurs, eliminating the need to wait for complete adhesion before securing the implant.
Solution Approach 2:
The rigid stent framework acts as an intermediary between the absorbent material and the valvular ring. The framework provides immediate mechanical support and anchoring, while the absorbent material provides progressive adhesion over time, combining the benefits of both immediate stability and long-term integration.
3Object-affected harmful factors
If the valve is designed to seal the anchor point, then perivalvular leaks are prevented, but the sealing mechanism must work with the anchoring structure
Solution Approach 1:
The sealing mechanism is merged with the anchoring flanges, where the lower anchoring flange includes both anchoring elements that engage the valvular ring and sealing elements that prevent perivalvular leaks. This integration ensures that the same structure provides both mechanical attachment and leak prevention, eliminating the need for separate sealing components.
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 proposed solution enables secure anchoring, prevents perivalvular leaks, and ensures normal functioning of the valve post-implantation, addressing the limitations of existing designs and providing a profound medical implication for both new and conventional valve designs.
Implementation Method 1
a cuff comprising an absorbent material disposed at least partially circumferentially around the outer surface of the stent, wherein the absorbent material expands by absorption of a fluid to substantially adhere the prosthesis at an implantation site
Data Source
AI summary
The present disclosure relates to valve replacement devices that are foldable for catheter-based deployment to the site of implantation, as well as systems for the delivery of valve prostheses, including prostheses having the special characteristics of the disclosed valve replacement devices. The devices include highly effective adhering mechanisms for secure and enduring precision implantation. The adhering mechanisms may employ a unique sealing mechanism that includes a cuff that expands slowly whereby the device is not secured in place until the completion of the implantation procedure. The implanted device, optionally together with the cuff, prevents perivalvular leaks and incorporate an appropriate leaflet system for reliable functioning in situ.