Anti-Paravalvular Leakage Component for Transcatheter Valve
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Solution Overview
Problem
Transcatheter valve prostheses often experience paravalvular leakage due to gaps between the support frame of the prosthesis and native valve tissue, which can lead to significant pressure gradients and blood leakage.
Innovation Solution
An anti-paravalvular leakage component is integrated onto the outer surface of the transcatheter valve prosthesis, comprising self-expanding segments and an annular sealing element. The segments are attached to the stent at spaced apart points and curve radially away from the stent in an expanded configuration, providing a flexible seal around the perimeter of the prosthesis.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a transcatheter valve prosthesis is delivered percutaneously with a compressed stent structure, then the valve can be advanced through the vasculature, but gaps form between the stent and native valve tissue causing paravalvular leakage
Solution Approach 1:
The anti-paravalvular leakage component is divided into multiple self-expanding segments that can independently conform to the native valve tissue. Each segment is attached to the stent at spaced apart points, allowing the component to flex and adapt to irregular valve anatomy while maintaining sealing contact throughout the circumference.
Solution Approach 2:
The anti-paravalvular leakage component transitions from a compressed state during delivery to an expanded state at the valve site. The self-expanding segments dynamically adjust their configuration based on the native valve anatomy, allowing the component to seal effectively against calcified or irregular valve surfaces.
2Stability of the object's composition
If calcified native leaflets are pressed against the stent frame, then the valve structure is stabilized, but complete conformance is prevented leading to leakage gaps
Solution Approach 1:
The anti-paravalvular leakage component has different local properties along its circumference. The segments are designed with varying degrees of flexibility and expansion capability to match local valve anatomy. Areas with calcified or irregular leaflets receive segments that can conform more aggressively, while other areas maintain standard contact pressure.
Solution Approach 2:
The anti-paravalvular leakage component combines rigid attachment points to the stent with flexible self-expanding segments. This composite structure allows the component to maintain stable attachment to the stent frame while the segments independently adapt to the native valve tissue, bridging the gap between stability and conformance.
3Force
If the stent structure is expanded to hold the prosthetic valve in place, then the valve is secured, but pressure gradients cause blood to leak through gaps
Solution Approach 1:
The anti-paravalvular leakage component acts as an intermediary element between the stent frame and the native valve tissue. It translates the radial force from the stent into distributed contact pressure along the valve perimeter, filling gaps and preventing blood leakage while maintaining the securing function of the stent.
Solution Approach 2:
The anti-paravalvular leakage component functions as a flexible sealing shell that conforms to the native valve anatomy. The self-expanding segments create a flexible barrier that adapts to the valve surface, preventing blood flow through gaps while allowing the stent to maintain its radial securing force.
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 anti-paravalvular leakage component effectively seals gaps between the prosthesis and native valve tissue, reducing or eliminating blood leakage and improving the sealing performance of the transcatheter valve prosthesis.
Implementation Method 1
The anti-paravalvular leakage component includes a plurality of self-expanding segments... In the expanded configuration, the segments curve radially away from the outer surface of the tubular stent
Data Source
AI summary
A transcatheter valve prosthesis includes an expandable tubular stent, a prosthetic valve within the stent, and an anti-paravalvular leakage component coupled to and encircling the tubular stent. The anti-paravalvular leakage component includes a radially-compressible annular scaffold, which is a sinusoidal patterned ring of self-expanding material, and an impermeable membrane extending over the annular scaffold. The anti-paravalvular leakage component has an expanded configuration in which at least segments of the annular scaffold curve radially away from the tubular stent. Alternatively, the anti-paravalvular leakage component includes a plurality of self-expanding segments and an annular sealing element coupled to inner surfaces of the segments. The anti-paravalvular leakage component has an expanded configuration in which the segments curve radially away from the tubular stent and the annular sealing element is positioned between an outer surface of the tubular stent and inner surfaces of the segments. The segments may be orthogonal or oblique to the outer surface of the tubular stent.