Conformable Occluder Seals Paravalvular Gaps in Self-Expanding Heart Valves
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Solution Overview
Problem
Conventional collapsible prosthetic heart valves face challenges with accurate deployment and anchoring, leading to risks such as valve migration and paravalvular leakage due to anatomical variations and calcification, which can result in severe clinical complications and reduced cardiac efficiency.
Innovation Solution
The use of a conformable occluder device with an expandable body, fastener, and disk to securely position and seal the prosthetic heart valve within the native valve annulus, reducing the need for excessive radial force and promoting a secure fit without harming nearby anatomy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If conventional collapsible prosthetic heart valves are deployed, then the valve can be implanted less invasively via catheter delivery, but inaccurate deployment and anchoring occur leading to valve migration and paravalvular leakage
Solution Approach 1:
The occluder device acts as an intermediary component between the prosthetic heart valve and the native valve annulus. It is delivered through the valve leaflets and deployed within the valve to provide additional anchoring and sealing, thereby improving deployment accuracy and preventing valve migration without requiring more invasive surgical approaches
Solution Approach 2:
The solution divides the sealing function into multiple components: the prosthetic heart valve itself and the separate occluder device. The occluder is delivered independently through the valve structure and deployed separately to address specific gaps, allowing for more precise and reliable sealing without compromising the less invasive delivery method
2Strength
If excessive radial force is applied to secure the prosthetic valve, then anchoring improves, but nearby anatomy is harmed
Solution Approach 1:
The occluder device applies sealing force locally at specific gap locations rather than distributing excessive radial force across the entire valve structure. By targeting only the necessary areas for sealing, it achieves adequate anchoring strength while minimizing harm to surrounding anatomical structures
Solution Approach 2:
The occluder serves as a mediator that provides additional anchoring through its own structural support and sealing mechanism, allowing the prosthetic valve to achieve secure fixation without requiring excessive radial force that would damage nearby anatomy
3Shape
If the prosthetic valve is released and expanded, then the valve reaches full operating size, but gaps remain between the valve and native valve annulus due to anatomical variations and calcification
Solution Approach 1:
The sealing function is segmented into the primary valve structure and the additional occluder component. The occluder is specifically designed to address gaps caused by anatomical variations and calcification by being delivered through the valve leaflets and deployed within the valve structure to provide targeted sealing enhancement
Solution Approach 2:
The occluder device is delivered and positioned within the prosthetic valve structure before final deployment. This preliminary positioning allows the occluder to be precisely placed to address anticipated gaps between the expanded valve and the native valve annulus, improving sealing precision before the valve begins its sealing function
Data Source
AI summary
An occluder for sealing gaps between a medical device and adjacent body tissue includes an expandable body configured to fill the gaps between the medical device and the body tissue. The occluder includes a fastener at one end of the body and adapted to couple to a first end of the medical device, and an expandable disk at the other end of the body and adapted to couple to the medical device at a position spaced from the first end.