Woven Loop Sealing Element for Prosthetic Heart Valve Leakage
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Solution Overview
Problem
Existing prosthetic heart valves face challenges in achieving a secure seal with the native annulus due to diameter differences and anatomical variations, leading to paravalvular leakage.
Innovation Solution
The use of a sealing element with interwoven filaments forming loops that extend radially outward from the frame, promoting thrombus formation and conforming to the surrounding anatomy to enhance sealing properties.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a sealing element is added to reduce paravalvular leakage, then sealing performance is improved, but device complexity increases
Solution Approach 1:
The sealing element is integrated within the prosthetic valve structure, with the skirt portion extending from the valve frame and the loop-forming filaments embedded within the woven fabric structure. This nesting approach allows the sealing function to be incorporated without adding a separate external component, thereby improving sealing performance while minimizing increases in overall device complexity.
Solution Approach 2:
The sealing element combines multiple functions into a single structure: the woven fabric provides structural support and radial strength, while the loop-forming filaments provide the sealing mechanism. This merging of structural and sealing functions into one integrated component improves sealing performance without requiring additional separate parts, thus avoiding excessive complexity.
2Reliability
If loop-forming filaments are used to promote thrombus formation, then sealing performance is improved, but object-generated harmful factors increase
Solution Approach 1:
The patent intentionally utilizes the harmful effect of thrombus formation as a beneficial sealing mechanism. The loop-forming filaments are specifically designed to promote thrombus formation, which then creates a biological seal between the prosthetic valve and the native annulus. This converts the potentially harmful thrombus formation into a useful sealing function, addressing paravalvular leakage through a biological rather than purely mechanical means.
3Reliability
If the sealing element conforms to irregular anatomy, then sealing performance is improved, but manufacturing precision becomes more difficult
Solution Approach 1:
The sealing element is designed with inherent flexibility and adaptability, allowing it to dynamically conform to irregular anatomical structures during implantation. The woven fabric structure with loop-forming filaments can deform and adapt to the specific geometry of the native annulus, providing a customized seal for each patient's unique anatomy without requiring pre-manufacturing customization or complex precision engineering for each case.
Solution Approach 2:
The sealing element's physical parameters such as fabric weave density, filament loop size, and material composition can be adjusted during manufacturing to optimize performance for different anatomical conditions. This allows the same basic manufacturing process to produce sealing elements with varying degrees of flexibility and conformability, maintaining manufacturing precision while adapting to different sealing requirements.
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 looped filaments effectively reduce blood leakage by obstructing flow, promoting thrombus formation, and conforming to the native annulus, thereby improving the seal and reducing the risk of complications.
Implementation Method 1
promoting thrombus formation and conforming to the surrounding anatomy to enhance sealing properties
Data Source
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AI summary
An implantable prosthetic valve that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration includes an annular frame having an inflow end, an outflow end, and a longitudinal axis. A leaflet structure is positioned within the frame and secured thereto, and a sealing element is secured to the frame. The sealing element includes a first woven portion extending circumferentially around the frame. The first woven portion includes a plurality of interwoven filaments. The sealing element further includes a second woven portion extending circumferentially around the frame and spaced apart from the first woven portion along the longitudinal axis of the frame. At least a portion of the filaments exit the weave of the first woven portion and form loops extending radially outwardly from the frame.