Conical Prosthetic Heart Valve with Flow Modulation
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Solution Overview
Problem
Current prosthetic heart valves, including mechanical, allograft tissue, and xenograft tissue valves, face issues such as blood clot formation, calcification, cytotoxicity, disruption of blood flow, and the need for anticoagulant medications, which can lead to complications like stroke and heart failure.
Innovation Solution
Development of non-remodelable prosthetic xenograft valves with a conical shape and flow modulation means, such as conical sheet or ribbon structures, made from collagenous mammalian tissue like pericardium, which reduce blood flow disruption and calcification, and can deliver biologically active agents to improve cardiovascular tissue health.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If mechanical or bioprosthetic valves are used to replace diseased heart valves, then valve dysfunction is treated, but blood clot formation occurs requiring anticoagulant medications
Solution Approach 1:
The patent applies parameter changes by modifying the surface properties of the prosthetic valve through specific material selection and surface treatment. The valve is constructed from materials with controlled surface energy, porosity, and chemical composition to create a non-thrombogenic surface that prevents blood clot formation without requiring anticoagulant medications, thus changing the physical-chemical parameters of the valve surface to eliminate the harmful effect.
Solution Approach 2:
The patent employs composite materials by combining multiple materials with complementary properties in a single valve structure. The valve incorporates a framework made from one material (providing mechanical strength) combined with a blood-contacting surface layer made from a different material (providing non-thrombogenic properties). This composite structure allows the valve to simultaneously achieve mechanical reliability and blood compatibility without requiring anticoagulants.
2Reliability
If conventional prosthetic valves are used, then valve replacement is achieved, but calcification and cytotoxicity occur over time
Solution Approach 1:
The patent applies parameter changes by controlling the chemical composition and physical properties of the valve materials to resist calcification. The materials are selected and processed to have specific surface energy, porosity, and chemical resistance parameters that prevent calcium deposition and cytotoxic effects, thereby extending the operational duration of the valve while maintaining replacement function.
Solution Approach 2:
The patent employs porous materials with controlled pore size, distribution, and connectivity to prevent calcification and improve durability. The porous structure allows for better blood compatibility, reduced stress shielding, and enhanced resistance to degenerative changes including calcification, thereby extending the valve's service life while maintaining its replacement function.
3Reliability
If traditional valve designs are used, then valve replacement is performed, but blood flow disruption occurs causing turbulence and pressure gradients
Solution Approach 1:
The patent applies spheroidality and curvature principles by designing the valve with smooth, curved surfaces and optimized geometries that promote laminar blood flow. The valve leaflets, frame, and flow channels are shaped with continuous curves rather than sharp angles, reducing flow separation, turbulence, and pressure gradients, thereby eliminating blood flow disruption while maintaining valve replacement capability.
Solution Approach 2:
The patent employs multi-functionality by designing a valve structure that simultaneously achieves multiple functions: mechanical support, blood flow guidance, and turbulence reduction. The integrated design incorporates flow-directing elements and pressure-distributing features that work together to maintain smooth blood flow while providing adequate valve support, thus reducing harmful flow disruption effects.
4Reliability
If prosthetic valves are implanted, then valve dysfunction is corrected, but anticoagulant medications are required leading to stroke and heart failure complications
Solution Approach 1:
The patent applies parameter changes by fundamentally altering the surface characteristics of the prosthetic valve to achieve non-thrombogenicity. Through controlled modification of surface energy, roughness, porosity, and chemical composition, the valve surface prevents blood clot formation, thereby eliminating the need for anticoagulant medications and their associated complications such as stroke and heart failure, while maintaining restored valve function.
Solution Approach 2:
The patent converts the harmful interaction between prosthetic valve surfaces and blood (which typically causes clot formation) into a beneficial non-thrombogenic interaction. By carefully engineering the surface properties, the valve transforms the blood-contact interface from a clot-promoting surface to a clot-repellent surface, thereby eliminating anticoagulant requirements and their complications while maintaining effective valve function.
Data Source
AI summary
Prosthetic heart valves having a conical shaped base valve structure formed from collagenous mammalian tissue. The base valve structure includes a plurality of elongated ribbon members that are positioned proximate each other in a joined relationship, wherein the elongated ribbon members are positioned adjacent each other and form a plurality of fluid flow modulating regions that open when fluid into and through the base valve structure exhibits a positive pressure relative to the exterior pressure, i.e., a positive pressure differential, wherein the fluid is allowed to be transmitted out of the base valve structure, and transition to a closed configuration when the pressure differential between the interior valve pressure and exterior pressure reduces, wherein the fluid is restricted from flowing out of the base valve structure.