Commissure-Supported Prosthetic Heart Valve for Small Annuli
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Smaller diameter prosthetic heart valves face challenges such as high pressure gradients, native leaflet overhang, limited 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 an expandable annular frame and quadrilateral leaflets, featuring commissure support members and preassembled commissure tab assemblies, which allow for wider leaflet opening, reduced pressure gradients, and maintained access to coronary arteries, facilitating easier alignment and implantation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Volume of moving object
If smaller diameter prosthetic valves are used, then the valve size is reduced for better fit, but pressure gradients increase leading to cavitation risks
Solution Approach 1:
The patent extends the valve frame in the axial dimension by adding bellows structures at the inflow and outflow ends. This allows the valve to maintain a smaller radial diameter while compensating for the reduced flow area through increased axial length, thereby reducing pressure gradients without increasing the valve's footprint in the radial direction.
Solution Approach 2:
The patent modifies the geometric parameters of the valve by incorporating bellows structures that change the axial length and surface area of the frame. This parameter change allows the valve to maintain adequate flow area despite a reduced diameter, addressing the pressure gradient issue while preserving the benefits of a smaller valve size.
2Volume of moving object
If smaller diameter prosthetic valves are used, then the valve fits smaller annuli, but paravalvular sealing elements become shorter making alignment more challenging
Solution Approach 1:
The patent compensates for the reduced circumferential length of sealing elements by extending them in the axial dimension through bellows structures. This dimensional transformation allows the sealing elements to maintain adequate contact length for proper alignment and sealing despite the smaller valve diameter.
Solution Approach 2:
The bellows structures provide dynamic expansion and contraction capability, allowing the sealing elements to adapt to variations in the native annulus geometry during implantation, thereby facilitating easier alignment even with shorter sealing elements.
3Volume of moving object
If smaller diameter prosthetic valves are used, then the valve size is reduced, but frame openings become smaller inhibiting coronary access
Solution Approach 1:
The patent addresses the reduced frame opening size by extending the axial length of the frame with bellows structures. This creates additional vertical space that allows coronary catheters to access and pass through the frame openings despite the smaller radial diameter, maintaining coronary accessibility while preserving the compact valve size.
4Volume of moving object
If smaller diameter prosthetic valves are used, then the valve fits smaller annuli, but valve-in-valve procedures become more difficult due to alignment and orientation challenges
Solution Approach 1:
The bellows structures extend the axial profile of the valve, creating distinct inflow and outflow ends that facilitate proper orientation during valve-in-valve procedures. This dimensional extension provides visual and tactile cues for correct alignment, reducing the complexity of implanting a second valve within a previously implanted smaller valve.
Data Source
AI summary
A method for assembling a prosthetic heart valve can include forming a leaflet assembly from a plurality of leaflets. Each leaflet can include opposing commissure tabs. The leaflet assembly can be formed by pairing a commissure tab of each leaflet with an adjacent commissure tab of an adjacent leaflet and connecting each pair of commissure tabs to a commissure support member to form a respective commissure assembly of the leaflet assembly. The method can further include positioning the leaflet assembly within an interior of an expandable annular frame. The frame can define a plurality of openings. The method can further include inserting each of the commissure assemblies through a respective opening of the frame so as to position the commissure assemblies on an exterior of the frame.