Foldable Prosthetic Heart Valve Using Flexible Substrate
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Solution Overview
Problem
Current prosthetic heart valves are either costly and time-consuming to produce using handsewn construction or require extracellular matrix scaffolds that are not fully functional, and they necessitate lifelong anticoagulant therapy for mechanical valves or limited lifespan for xenografts.
Innovation Solution
A prosthetic heart valve constructed from a flexible substrate that can be folded into a cylindrical shape with leaflet and outer wall-defining regions, allowing for a simpler and more efficient fabrication process, reducing stress concentrations and enabling the use of a wider range of biocompatible materials.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If handsewn construction is used to fabricate prosthetic heart valves, then the valve can be constructed with precision, but the manufacturing process becomes time-consuming and costly
Solution Approach 1:
The flexible substrate is divided into distinct leaflet-defining regions and outer wall-defining regions, allowing each region to be optimized independently while simplifying the overall fabrication process. This segmentation enables precise valve construction without requiring time-consuming handsewn assembly of multiple components.
Solution Approach 2:
The invention merges the leaflet structure and outer wall structure into a single integrated flexible substrate. This combination eliminates the need for separate handsewn assembly operations, significantly improving manufacturing efficiency while maintaining construction precision through the unified foldable design.
2Duration of action of stationary object
If mechanical valves are used, then the valve provides durable function, but the patient requires lifelong anticoagulant therapy
Solution Approach 1:
The invention changes the material parameter from traditional mechanical materials to flexible biocompatible materials that can be folded. This parameter change enables the use of materials that do not require anticoagulant therapy while maintaining durable function through the foldable construction that reduces stress concentrations.
3Adaptability or versatility
If extracellular matrix scaffold is used to grow living valve, then the valve can be made from patient's own tissue, but the current scaffolds are not fully functional
Solution Approach 1:
The invention uses a flexible substrate that can be folded into the desired valve configuration. This flexible shell approach provides a simpler and more reliable alternative to complex ECM scaffolds, maintaining tissue compatibility while ensuring full functionality through the inherent mechanical properties of the foldable structure.
4Strength
If traditional rigid valve construction is used, then the valve provides structural strength, but stress concentrations develop that limit lifespan
Solution Approach 1:
The invention transitions from rigid static construction to a dynamic foldable design that can adapt to mechanical stresses. The flexible substrate allows stress distribution through folding mechanisms, eliminating stress concentrations while maintaining structural strength and extending valve lifespan.
Data Source
AI summary
A prosthetic heart valve is constructed from a flexible substrate that can be folded from an unfolded configuration to a folded configuration, in which the prosthesis is operable as a prosthetic heart valve. The prosthetic heart valves can be designed as atrioventricular valves (e.g., tricuspid valve, mitral valve) or as semilunar valves (e.g., aortic valve, pulmonary valve).