Tri-leaflet Prosthetic Heart Valve Stent Frame Weaving
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Solution Overview
Problem
Current prosthetic heart valves for aortic and mitral heart valve replacement procedures are prone to thromboembolism, requiring lifelong anticoagulation therapy, or they undergo valve degeneration and tissue failure, necessitating reoperation.
Innovation Solution
A prosthetic heart valve design featuring a stent frame with a first upper frame portion, a base, and stent posts, integrated with a sheet of leaflet material that weaves through the stent frame, providing improved durability and reduced need for anticoagulation therapy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If mechanical or bioprosthetic valves are used for heart valve replacement, then valve replacement can be performed, but the patient faces significant risk of thromboembolism requiring lifelong anticoagulation therapy or valve degeneration requiring reoperation
Solution Approach 1:
The stent frame is designed with a porous structure comprising multiple struts that create interstitial spaces. This porous architecture allows blood flow through the framework while providing structural support, reducing stagnant flow areas that promote thrombus formation. The porous design maintains valve durability while mitigating thromboembolism risk through improved hemodynamics.
Solution Approach 2:
The prosthetic valve combines different materials with complementary properties: a metallic stent frame (stainless steel, cobalt-chromium, or nickel-titanium alloy) providing structural strength, and biological leaflet material (porcine or bovine pericardium) providing natural blood compatibility. This composite construction achieves both durability and reduced thromboembolism risk by integrating the advantages of each material.
2Reliability
If mechanical or bioprosthetic valves are used for heart valve replacement, then valve replacement can be performed, but the patient becomes more prone to valve degeneration and tissue failure requiring reoperation
Solution Approach 1:
The stent frame geometry is optimized with specific strut thicknesses (0.5-2.0 mm), lengths (10-50 mm), and spacing patterns that balance structural strength with flexibility. The frame includes compression members and triangulated configurations that distribute mechanical stresses, preventing fatigue failure and extending valve service life while maintaining durability.
Solution Approach 2:
The stent frame incorporates flexible segments and joints that allow the structure to adapt dynamically to cardiac cycle pressures and movements. This dynamic design enables the frame to flex with heart motion rather than resisting it, reducing stress concentrations that lead to degeneration and extending the functional lifespan of the prosthetic valve.
3Ease of manufacture
If traditional prosthetic valve assembly methods are used, then valve construction can be achieved, but a large number of sutures are required for assembly
Solution Approach 1:
The leaflet material is integrated directly with the stent frame structure through weaving or suturing at specific attachment zones, combining what would traditionally be separate components into a unified assembly. This merging reduces the number of discrete suture lines needed and simplifies the overall construction process while maintaining structural integrity.
Solution Approach 2:
The leaflet material is pre-attached to specific portions of the stent frame during manufacturing, with attachment zones positioned at the distal ends of vertical struts. This preliminary attachment simplifies final assembly by reducing the number of suture operations required during implantation and standardizing the construction process.
Data Source
AI summary
A prosthetic heart valve includes a first upper frame portion and a stent frame connected to the first upper frame portion via at least two stent frame extensions. The stent frame includes a base and at least two stent posts extending upwardly from the base towards the first upper frame portion. The first upper frame portion, the base, and the at least two stent posts each has an inner surface and an outer surface. The prosthetic heart valve also includes at least one sheet of leaflet material configured to encircle the stent frame and weave through the stent frame between the first upper frame portion and the base.