Prosthetic Heart Valve Commissure Assembly for Low Pressure Gradients
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Solution Overview
Problem
Existing smaller diameter prosthetic heart valves face challenges such as higher pressure gradients, native leaflet overhang, reduced frame openings, and difficulty in aligning and orienting a second prosthetic valve during valve-in-valve procedures, which can lead to clinical risks and complications.
Innovation Solution
The development of a prosthetic heart valve with a novel leaflet assembly and frame design, featuring quadrilateral leaflets with axially offset outflow edges, commissure support members, and preassembled commissure tab assemblies, allowing for wider leaflet opening and reduced pressure gradients, while maintaining access to coronary arteries.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Volume of moving object
If smaller diameter prosthetic valves are used, then valve size is reduced for smaller patients, but pressure gradients increase leading to cavitation and higher clinical risks
Solution Approach 1:
The valve is segmented into multiple functional components: a collapsible support structure with radial struts, separate leaflet assemblies with commissure tabs, and modular sealing elements. This segmentation allows optimization of each component's geometry to reduce pressure gradients while maintaining small overall valve diameter.
Solution Approach 2:
The patent transitions from traditional planar leaflet attachment to three-dimensional commissure tab assemblies that extend radially outward and attach to the support structure at multiple points. This dimensional change increases the effective flow area and reduces pressure gradients across the valve.
2Volume of moving object
If smaller diameter prosthetic valves are used, then valve size is reduced, but paravalvular sealing elements become shorter making alignment more challenging
Solution Approach 1:
The commissure tab assemblies are pre-formed with attachment features that engage with corresponding receptacles on the support structure before final valve deployment. This preliminary assembly ensures proper alignment and positioning of sealing elements relative to the valve annulus.
Solution Approach 2:
The commissure tab assemblies serve as intermediary structures that mediate between the leaflet bodies and the support structure. These tabs provide attachment points and geometric reference features that facilitate accurate alignment during implantation procedures.
3Volume of moving object
If smaller diameter prosthetic valves are used, then valve size is reduced, but frame length becomes relatively shorter causing leaflet overhang that disturbs blood flow
Solution Approach 1:
The support structure employs collapsible radial struts that can dynamically adjust their length and position. During deployment, the struts expand to provide adequate frame length for proper leaflet positioning, preventing overhang while maintaining a compact compressed profile for delivery through small access vessels.
Solution Approach 2:
The patent changes the geometric parameters of the support structure, specifically increasing the radial length of struts and adjusting the angle of leaflet attachment. These parameter changes ensure that leaflets are positioned optimally within the valve frame, preventing overhang and maintaining smooth blood flow patterns.
4Volume of moving object
If smaller diameter prosthetic valves are used, then valve size is reduced, but frame openings become smaller inhibiting coronary access in subsequent procedures
Solution Approach 1:
The support structure employs asymmetric strut positioning and varying opening sizes throughout the valve circumference. Larger openings are strategically positioned to align with coronary artery ostia, providing adequate access for subsequent coronary procedures while maintaining small overall valve diameter.
Solution Approach 2:
Different regions of the valve frame have different opening characteristics. The patent creates local quality variations with larger, more accessible openings in specific angular positions to facilitate coronary access, while other regions maintain smaller openings appropriate for the overall small valve diameter.
5Adaptability or versatility
If valve-in-valve procedures are performed with smaller prosthetic valves, then re-intervention is enabled, but alignment and orientation of the second valve become more difficult
Solution Approach 1:
The valve design incorporates universal features including external commissure tab assemblies and standardized attachment mechanisms that serve multiple functions: they define the valve orientation, provide alignment references for subsequent valve-in-valve procedures, and enable secure anchoring. These features make the valve particularly suitable for future re-intervention while maintaining ease of alignment.
Data Source
AI summary
A prosthetic heart valve includes an expandable annular frame having an inflow end, an outflow end, an interior, an exterior, a plurality of openings, and a longitudinal axis; a plurality of commissure supports members outside of the frame; and a plurality of quadrilateral valve leaflets each having a main body having an inflow edge and an outflow edge, and a pair of opposing leaflet tabs extending from opposite sides of the main body, each leaflet tab being paired with an adjacent leaflet tab of an adjacent leaflet, each pair of leaflets tabs extending through a respective opening of the frame and coupled to one of the commissure supports to form a commissure tab assembly, wherein each commissure tab assembly is located on the exterior of the frame and the main body of each leaflet is located on the interior of the frame.