Occlusion Device with Rounded Edges for Paravalvular Leak Sealing
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Solution Overview
Problem
Existing occlusion devices for paravalvular leaks disrupt blood flow, provide insufficient sealing, and fail to adapt to the irregular anatomy of the implantation site, leading to complications such as embolization, stroke, and increased morbidity.
Innovation Solution
A medical occlusion device with a fabric of threads that can expand and collapse, featuring varying radii of curvature for secure anchoring and minimal disruption, allowing flexible positioning and secure attachment to varying anatomical sites, ensuring unrestricted blood flow and effective sealing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If existing occlusion devices are used to treat paravalvular leaks, then occlusion of the leak is achieved, but blood flow disruption occurs leading to embolization and stroke risks
Solution Approach 1:
The device applies local quality by creating a seal only at the paravalvular leak site using an irregularly shaped disc that conforms to the specific anatomy of the leak, while leaving the rest of the blood flow path untouched. This localized sealing approach prevents blood flow disruption in non-affected areas, reducing embolization and stroke risks while maintaining effective occlusion at the target site.
Solution Approach 2:
The device incorporates a flexible membrane that can dynamically adapt to the irregular anatomy of the paravalvular leak. The membrane's ability to flex and conform to varying anatomical shapes allows it to maintain an effective seal while accommodating normal blood flow dynamics, thereby preventing both leakage and flow disruption.
2Reliability
If existing occlusion devices are used, then occlusion is achieved, but insufficient sealing occurs due to inability to adapt to irregular anatomy
Solution Approach 1:
The device features an irregularly shaped disc with varying radii of curvature that matches the specific anatomical irregularities of the paravalvular leak site. This local customization ensures optimal contact and sealing at the unique geometry of each leak, preventing insufficient sealing that occurs with standardized devices.
Solution Approach 2:
The flexible membrane can dynamically adapt its shape to conform to the irregular anatomy of the paravalvular leak. This adaptability allows the device to achieve effective sealing across varying anatomical configurations, solving the problem of insufficient sealing in non-standard anatomical situations.
3Reliability
If existing occlusion devices are used, then occlusion is attempted, but device complexity increases leading to difficult implantation and higher morbidity
Solution Approach 1:
The device is segmented into two main components: an irregularly shaped disc for anchoring and sealing, and a flexible membrane for occlusion. This segmentation allows each component to be optimized independently - the disc for anatomical conformity and the membrane for sealing - while simplifying the overall implantation process compared to more complex multi-component systems.
Solution Approach 2:
The invention extracts the essential sealing function from complex mechanical systems and implements it through a simple flexible membrane that conforms to the anatomy. This extraction of the core sealing mechanism from complex actuation systems reduces device complexity and implantation difficulty while maintaining effective occlusion.
Data Source
AI summary
A medical occlusion device with proximal and distal portions separated by a connecting member. The proximal and distal portions are shaped to reduce the occurrence of paravalvular leakage by including a peripheral edge that is characterized by rounded corners.