Compressible Stent Prosthetic Heart Valve with Polymeric Leaflets
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Solution Overview
Problem
Traditional heart valve replacement methods require open heart surgery, which is invasive, costly, and poses risks, while minimally invasive procedures face challenges such as leaflet design issues leading to regurgitation, stagnation, and high stress, limiting haemodynamic performance and accessibility.
Innovation Solution
A prosthetic heart valve with a compressible and expandable stent design featuring polymeric leaflets moulded directly onto the stent, with arch-shaped elements and reinforcing members to reduce stress and ensure proper coaptation, manufactured through dip or spray moulding processes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If traditional open heart surgery is used for valve replacement, then complete access to the heart is achieved, but the procedure becomes highly invasive, costly, and carries significant risks
Solution Approach 1:
The patent employs a catheter as an intermediary device to deliver the prosthetic valve through the vascular system (femoral artery) rather than requiring direct surgical access to the heart. The catheter serves as a mediator that transports the compressed valve from the peripheral site to the target location, enabling minimally invasive valve replacement while maintaining complete access to the heart through the vascular pathway.
Solution Approach 2:
The patent replaces the mechanical surgical incision and direct surgical access system with a percutaneous transluminal delivery system. Instead of making a thoracic incision to access the heart, the valve is delivered through the vascular system using a catheter, substituting the surgical mechanical access method with a less invasive percutaneous approach.
2Reliability
If leaflets are designed to coapt closely to prevent regurgitation, then valve closure is improved, but blood wash-out is limited and stagnation regions form encouraging thrombogenesis
Solution Approach 1:
The patent applies different geometric characteristics to different regions of the leaflet. The free edge of the leaflet is designed with a specific curvature and thickness distribution that creates a gradual coaptation zone rather than a sharp closure line. This local variation in geometry allows for effective sealing while maintaining blood flow pathways that prevent stagnation and thrombogenesis in the commissural regions.
3Reliability
If valve leaflets are made to close fully to prevent regurgitation, then valve function is improved, but high stresses develop at commissures or in leaflet belly regions leading to damage
Solution Approach 1:
The patent modifies the geometric parameters of the leaflet, specifically the thickness distribution and curvature of the free edge. By optimizing these parameters, the leaflet achieves full coaptation for effective valve function while distributing mechanical stresses more evenly throughout the leaflet structure. The thickness variation and curved geometry prevent stress concentration at the commissures and in the leaflet belly, reducing the risk of fatigue-related damage.
4Object-affected harmful factors
If minimally invasive procedures are used for valve replacement, then surgical risks are reduced, but highly specialised equipment is required making procedures expensive and less accessible
Solution Approach 1:
The patent designs a valve delivery system that can be integrated with existing vascular catheterization equipment rather than requiring entirely new specialized devices. The system utilizes standard interventional radiology and cardiology equipment for valve delivery, making the minimally invasive procedure more accessible and reducing the need for highly specialized equipment while maintaining the risk benefits of percutaneous access.
Data Source
AI summary
A prosthetic heart valve (10) which includes a stent (14) having three leaflets (12) attached thereto is provided. The stent (14) is compressible so as to be capable of being introduced into a patient's body through a minimally invasive procedure and has a ring-like body (16) defining in its height three arch-shaped elements (18). Each element (18) includes an arc (20) and a pair of haunches (22) extending from opposite sides thereof, with three commissural posts (26) formed by the haunches (22) of adjacent elements (18). The leaflets (12) each have an attachment edge (28) and a free edge (30) with a belly (32) extending therebetween. The leaflets (12) are movable between a coapted condition, in which the free edges (30) abut and prevent fluid flow through the valve (10), and an open condition, in which fluid flow through the valve (10) is permitted. The leaflets (12) are made from a polymeric material and are moulded directly onto the stent (14) so as to provide for continuous attachment thereof.