Crescent-Shaped Perivalvular Occlusion Stent
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Solution Overview
Problem
Current occlusion devices for perivalvular leaks around transcatheter and surgically implanted valves are not optimally designed to conform to the thin, crescent-shaped openings, often causing migration and interference with valvular function and blood flow.
Innovation Solution
A stent-like occlusion device with a covering and blocking fabric that expands to fill the oval or crescent-shaped leak path, preventing migration and maintaining blood flow blockage without interfering with valve function, using balloon expandable or self-expanding systems.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Shape
If standard occlusion devices with circular cross section are used, then device simplicity is maintained, but the device cannot conform to the thin, oval, crescent-shaped opening of perivalvular leaks
Solution Approach 1:
The occlusion device is divided into multiple segments or struts that can independently move and articulate. These segmented components allow the device to transform from a compact delivery configuration to an expanded configuration that conforms to the oval or crescent-shaped perivalvular leak opening, while maintaining structural control during delivery
Solution Approach 2:
The occlusion device incorporates dynamic elements that enable shape change during expansion. The device transitions from a simple circular cross-section in the delivery state to a complex oval or crescent shape in the deployed state, allowing it to match the irregular geometry of perivalvular leaks without requiring complex pre-formed structures
2Reliability
If flanges are added to prevent device migration, then device stability is improved, but valvular function and blood flow through the valve are interfered with
Solution Approach 1:
The occlusion device applies occlusion force locally at the perivalvular leak site through its expanded frame structure, rather than using distal flanges that would interfere with valve function. The device's stability is achieved through localized anchoring mechanisms at the treatment site, such as radial expansion against the annulus or engagement with surrounding tissue, eliminating the need for proximal or distal flanges
Solution Approach 2:
The harmful flange structure is completely removed from the device design. Instead of using flanges to prevent migration, the invention extracts this function and replaces it with alternative stabilization mechanisms that do not interfere with valvular function, such as self-expanding frames that anchor against the annulus or tissue engagement features at the leak site
3Reliability
If the device is designed to fully expand to block the leak, then leakage blockage is improved, but the device may migrate or interfere with normal blood flow
Solution Approach 1:
The occlusion device is designed to expand primarily at the region corresponding to the perivalvular leak, creating localized high-density occlusion material or frame structure at the leak site. This localized expansion achieves effective leak blockage while minimizing the device's overall profile and reducing interference with normal blood flow through the valve
Solution Approach 2:
The device utilizes parameter changes in its expansion characteristics, such as varying the expansion pressure, expansion timing, or expansion sequence of different device sections. This allows the device to achieve sufficient expansion for leak occlusion while controlling the expansion parameters to prevent over-expansion that could cause migration or interfere with adjacent structures
Data Source
AI summary
An occlusion device intended for blocking perivalvular leak channels that are found following heart valve implantation between the heart valve and the surrounding tissue. The occlusion device has a stent and a covering that is attached to the stent surface. A blocking fabric extends across the lumen of the stent to block blood flow. The stent pattern and wall structure provide for small radius of curvature bends to fill narrow channels that cause the perivalvular leaks.