Prosthetic Heart Valve Outer Sealing Member for Leaflet-Safe Sealing
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Solution Overview
Problem
Conventional prosthetic heart valves without an inner skirt face challenges in achieving effective circumferential and paravalvular sealing due to the absence of an inner skirt, leading to potential leaflet abrasion and assembly issues and increased manufacturing costs, as well as paravalvular leakage, which existing sealing members cannot effectively address these issues.
Innovation Solution
The prosthetic heart valve design includes a frame with a sealing member configured to provide both circumferential and paravalvular sealing, which is achieved by an outer sealing member disposed on an outer surface of the frame, comprising a base portion and angled portions, which are coupled to the frame, extending around the outer surface of the frame, which is configured to provide both improved sealing and sealing properties, thereby reducing the flow of blood radially inward through the frame from the external environment surrounding the leaflets.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If an inner skirt is used in conventional prosthetic heart valves, then circumferential sealing is improved, but the risk of leaflet abrasion increases and manufacturing complexity increases
Solution Approach 1:
The patent removes the inner skirt component from the prosthetic heart valve design, extracting the source of leaflet abrasion while maintaining circumferential sealing through an alternative sealing member configuration that contacts only the outer surface of the frame
Solution Approach 2:
The sealing member is positioned as an intermediary element on the outer surface of the frame, creating a seal between the frame and native tissue without requiring internal contact with leaflets, thus mediating the sealing function while avoiding harmful interactions
2Reliability
If an inner skirt is used in conventional prosthetic heart valves, then circumferential sealing is improved, but assembly time and manufacturing costs increase
Solution Approach 1:
The sealing function is merged with the outer surface mounting structure, eliminating the need for separate inner skirt assembly and reducing the number of components that require assembly, thereby improving productivity while maintaining sealing reliability
Solution Approach 2:
The sealing member serves multiple functions: providing circumferential sealing, preventing paravalvular leakage, and avoiding leaflet abrasion, all through a single component design that simplifies assembly while maintaining reliability
3Reliability
If an outer sealing member with slack is used, then paravalvular sealing is improved, but the sealing member material may protrude inwardly and contact leaflets
Solution Approach 1:
The sealing member is designed with localized slack positioned outwardly on the outer surface of the frame, allowing billowing for paravalvular sealing while the constrained inner surface prevents inward protrusion and leaflet contact, thus achieving local quality differentiation
4Device complexity
If no inner skirt is used in smaller-diameter prosthetic valves, then manufacturing complexity is reduced, but effective sealing becomes difficult to achieve
Solution Approach 1:
Instead of placing the sealing member internally as an inner skirt, the patent inverts the approach by positioning the sealing member on the outer surface of the frame, achieving sealing effectiveness while reducing device complexity for smaller-diameter valves
Data Source
AI summary
A prosthetic heart valve can include a frame and an outer sealing member disposed around an outer surface of the frame. The frame can include a plurality of rows of angled struts arranged to form a plurality of rows of cells defining openings in the frame, wherein the frame can be radially expandable and compressible between a radially expanded state and a radially compressed state. The outer sealing member can include a base portion extending around the outer surface of the frame and covering the openings of at least one of the rows of cells. The outer sealing member can further include at least one angled portion coupled to the base portion at an inflow end portion thereof and extending radially away from the base portion in a direction from the inflow end to an outflow end portion of the angled portion.