Prosthetic Venous Valve Leaflet Shear Rate Control
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Solution Overview
Problem
Current treatments for chronic venous insufficiency (CVI) primarily address symptoms rather than the source, and existing prosthetic venous valves face issues with biocompatibility, thrombogenicity, correct sizing, and durability, limiting their medical acceptance and use.
Innovation Solution
A novel prosthetic venous valve design made from biocompatible materials like infiltrated carbon nanotubes, engineered to mimic natural venous valve function, with specific shear rate ranges to minimize thrombus formation and promote effective blood flow, addressing biocompatibility and thrombogenicity concerns.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If compression therapy, laser ablation, sclerotherapy, or stripping is performed to treat CVI symptoms, then symptom relief is achieved, but the underlying venous valve dysfunction source remains untreated
Solution Approach 1:
The prosthetic venous valve is designed to copy and mimic the structure and function of a natural venous valve. It includes a valve body with a lumen and a valve leaflet that replicates the natural valve's geometry and hemodynamic function, allowing blood to flow in one direction while preventing retrograde flow. This copying approach enables the prosthetic to restore proper venous valve function without requiring complex surgical reconstruction of the damaged natural valve.
2Reliability
If traditional prosthetic venous valves are used, then valve replacement is achieved, but issues with biocompatibility, thrombogenicity, and durability limit their acceptance
Solution Approach 1:
The patent applies parameter changes by carefully controlling the shear rate parameters within the prosthetic valve design. The valve geometry and leaflet motion are designed to maintain shear rates within a specific range (46-3500 s^-1) that prevents thrombus formation. This parameter optimization addresses the thrombogenicity issue of traditional prosthetic valves while maintaining effective valve function.
Solution Approach 2:
The prosthetic valve incorporates composite material structures, including the valve body and leaflet constructed from materials designed to be biocompatible and thromboresistant. The use of composite materials combines the benefits of structural integrity with surface properties that minimize thrombus formation and enhance long-term durability within the vascular environment.
3Reliability
If valve reconstruction surgery is performed to address the source of CVI, then venous valve function can be restored, but long-term success rates are low and surgery may be impossible when the entire valve is destroyed
Solution Approach 1:
The prosthetic venous valve is designed as a pre-fabricated, ready-to-implant device that eliminates the need for complex surgical reconstruction procedures. The valve is manufactured with precise geometry and material properties optimized for long-term performance, allowing for straightforward implantation without the need for extensive surgical skill or prolonged procedural time. This preliminary preparation of the valve device improves both the ease of implantation and long-term success rates compared to surgical reconstruction.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The prosthetic venous valve effectively directs blood flow to the heart, reduces venous hypertension, and minimizes thrombosis risks, offering a potential long-term solution for CVI by mimicking natural venous valve dynamics and materials.
Implementation Method 1
A properly functioning venous system will return blood to the heart by means of the interaction of a central pump, a pressure gradient, a peripheral venous pump, and competent venous valves
Implementation Method 2
The purpose of venous valves is to direct blood back toward the heart and impede reverse flow
Data Source
AI summary
A prosthetic venous valve device is disclosed and described, having a valve base including a cylindrical shape with a lumen configured for axial blood flow, the valve base further including an anterograde end and a retrograde end, a pair of flexure pivots coupled to opposite sides of the valve base at the anterograde end, and a pair of leaflets opposingly positioned with respect to one another and each pivotally coupled to one of the pair of flexure pivots, the pair of leaflets being separated from one another in a default open position, wherein the pair of leaflets are structurally configured to pivot from the default open position toward one another to close the prosthetic venous valve to limit retrograde venous blood flow under normal physiologic venous conditions.