Adjustable Paravalvular Leak Occluder for Irregular Valve Gaps
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Solution Overview
Problem
Existing methods to address paravalvular leakage, such as surgical reattachment and use of embolic materials, are inadequate due to the variability in gap shape and size, leading to complications like clot formation and reduced blood flow.
Innovation Solution
A paravalvular leak occlusive device with adjustable metallic wire mesh, flanged ends, and a compliant waist region, deployed via a catheter, to seal the gap between the heart valve and vessel, utilizing adjustment mechanisms like springs or hydrogel expansion to conform to the gap geometry.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If embolic material is used to fill the gap, then the leakage can be addressed, but the variability in gap shape and size makes it difficult to size the embolic material correctly
Solution Approach 1:
The device incorporates an adjustment mechanism that allows the occlusive element to dynamically change its size and shape. The mechanism includes expandable elements such as balloons or self-expanding frameworks that can adapt to the specific gap geometry after deployment, enabling the device to conform to varying gap shapes and sizes while maintaining reliable occlusion.
Solution Approach 2:
The device enables parameter changes in the occlusive element's dimensions and configuration. Through adjustment mechanisms, the device can modify the size, shape, and volume of the occlusive element to match the specific gap characteristics, transforming a fixed-size embolic material into a dynamically adjustable structure that adapts to individual patient anatomy.
2Reliability
If smaller embolic materials are used, then they can fit smaller gaps, but they can migrate creating clot complications elsewhere in the vasculature
Solution Approach 1:
The device introduces an intermediary structure (the adjustable occlusive element with flanges) that acts as a mediator between the delivery system and the gap. The flanges provide anchoring points that prevent migration, while the adjustable occlusive element ensures proper sealing. This intermediary structure eliminates the need for small embolic materials that could migrate, as the device can be sized to match the gap exactly without risking vascular embolization.
3Reliability
If larger embolic materials are used, then they can fill larger gaps, but they are difficult to conform to the shape of the leakage region
Solution Approach 1:
The device uses dynamic adjustment mechanisms that allow the occlusive element to change its shape and conform to the gap geometry after deployment. The expandable structures can be compressed during delivery and then expand to match the specific shape of the leakage region, enabling large gaps to be sealed while maintaining conformance to the actual gap morphology.
Solution Approach 2:
The device incorporates flexible occlusive elements that can bend and conform to the gap shape. The occlusive element may include flexible membranes or frameworks that adapt to the three-dimensional geometry of the leakage region, allowing the device to seal large gaps while maintaining close contact with the irregular gap surfaces.
4Reliability
If surgical reattachment is performed, then the valve can be reattached to the vessel, but it often does not work or introduces additional complications
Solution Approach 1:
The device replaces complex surgical reattachment procedures with a minimally invasive endovascular solution. Instead of requiring open surgery to reattach the valve, the device uses a catheter-based delivery system to deploy an occlusive element that seals the gap from the inside, substituting complex mechanical surgical reattachment with a simpler endovascular sealing mechanism.
Solution Approach 2:
The device introduces an intermediary occlusive element that seals the gap between the valve and vessel without requiring direct reattachment surgery. The flanges and occlusive element act as intermediaries that prevent blood flow through the gap while avoiding the need for complex surgical reattachment, thereby reducing procedural complexity and potential complications.
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
Effectively seals the paravalvular leak, restoring normal blood flow and preventing complications by ensuring a secure fit and occlusion of the gap between the heart valve and vessel.
Implementation Method 1
a heart valve is described which utilizes an expansile material, such as hydrogel and/or foam, which expands at the treatment site in order to seal the heart valve against the blood vessel
Implementation Method 2
The adjustment mechanism can comprise, for example, a spring, tether, wire, and/or shaped braid
Data Source
AI summary
Heart valve replacement often involves complications associated with paravalvular leaks. Vascular plug and occlusive devices, as well as heart valves particularly beneficial in treating the phenomenon of paravalvular leaks are described to address this issue.