Transcatheter Heart Valve Sealing Structure for Low-Profile Leak Control
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Solution Overview
Problem
Existing prosthetic heart valves experience perivalvular leakage due to irregular native valve annulus shapes, leading to blood regurgitation, and current sealing devices increase the prosthetic valve's profile, making it difficult to advance through blood vessels.
Innovation Solution
Catheter-based prosthetic heart valves with collapsible and expandable sealing devices that minimize the overall profile by sliding or pivoting into position upon expansion, using tethers, biasing arms, or heat-set flaps to seal the interface with surrounding tissue without significantly contributing to the crimped state.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If sealing devices are added to prevent perivalvular leakage, then sealing effectiveness is improved, but the overall profile of the prosthetic valve increases
Solution Approach 1:
The sealing device is nested within the cell structures of the frame during the compressed state, with the sealing member positioned inside the cells rather than extending outward. This nesting approach allows the sealing function to be integrated without increasing the overall crimped profile of the valve, resolving the contradiction between sealing effectiveness and valve profile.
Solution Approach 2:
The sealing member is designed to be movable between a compressed state (nested within cells) and an expanded state (protruding to seal the annulus). The dynamic reconfiguration allows the sealing device to maintain a small profile during delivery while providing effective sealing upon deployment, addressing both the sealing effectiveness and profile constraints.
2Ease of operation
If the prosthetic valve profile is reduced to facilitate advancement through blood vessels, then ease of delivery is improved, but sealing capability may be compromised
Solution Approach 1:
The sealing device is nested within the frame's cell structures during the compressed state, allowing the valve to have a small profile for easy delivery through blood vessels. The sealing member is positioned inside the cells rather than extending outward, maintaining a compact crimped profile while preserving sealing capability upon expansion.
Solution Approach 2:
The sealing member transitions from a compressed nested state during delivery to an expanded sealing state at the implantation site. This dynamic behavior allows the valve to be easily delivered through vascular access points while providing effective sealing capability once deployed, resolving the contradiction between delivery ease and sealing capability.
Data Source
AI summary
A balloon-expandable prosthetic heart valve includes a collapsible and expandable frame. The frame includes an inflow end, an outflow end, and a plurality of closed cells. Each of the closed cells includes a pair of first angled struts that converge to form a first apex, a pair of second angled struts that converge to form a second apex, and a pair of side struts extending between the first pair of angled struts and the second pair of angled struts. Each side strut has a first end and a second end, and a width of each of the side struts varies from the first end to the second end.