Conformable Occluder Seals Paravalvular Gaps in Self-Expanding Heart Valves
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Solution Overview
Problem
Conventional collapsible prosthetic heart valves face challenges such as inaccurate deployment and anchoring, leading to valve migration, paravalvular leakage, and complications due to uneven calcification, which affect cardiac efficiency and increase procedural risks.
Innovation Solution
The use of a conformable occluder device with an expandable body, fastener, and disk to securely anchor and seal the prosthetic heart valve within the native valve annulus, reducing radial force and accommodating irregularities in patient anatomy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a self-expanding stent is used for the prosthetic heart valve, then the valve can be delivered less invasively via catheter, but the valve may migrate or cause paravalvular leakage due to inaccurate deployment and anchoring
Solution Approach 1:
The stent is divided into multiple expandable cells that can be independently controlled. Each cell can be expanded separately to accommodate irregularities in the patient's anatomy, allowing for precise positioning and secure anchoring while maintaining minimally invasive delivery through catheter-based deployment
2Reliability
If the prosthetic valve is expanded to full size at the implant site, then it can function properly, but uneven calcification of the native valve annulus causes inaccurate deployment and anchoring
Solution Approach 1:
The stent employs a dynamic expansion mechanism where cells can be expanded in a controlled sequence rather than simultaneously. This allows the stent to adapt to uneven calcification patterns by expanding more into areas with less calcification and less into areas with heavy calcification, achieving accurate deployment and secure anchoring despite anatomical variations
3Reliability
If conventional prosthetic valves are used, then valve replacement can be performed, but paravalvular leakage occurs due to gaps between the valve and native annulus
Solution Approach 1:
The stent features cells with varying expansion characteristics and sealing elements at specific locations to address local gaps between the prosthetic valve and native annulus. This localized adaptation allows the stent to conform to irregular annular geometry and eliminate paravalvular leakage pathways while maintaining overall valve function
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 conformable occluder effectively seals gaps between the prosthetic and native valves, reducing paravalvular leakage and improving cardiac performance by providing a secure, low-radial-force anchoring solution that adapts to individual patient anatomy.
Implementation Method 1
an expandable body having a first end and a second end... and an expandable disk coupled to the second end of the body
Data Source
AI summary
An occluder device for occluding a gap between a medical device and adjacent body tissue includes a conformable body having a hollow interior, a leading end and a trailing end; and a port disposed at the trailing end of the body and in fluid communication with the interior of the body.