Polymeric Heart Valve Surface Roughness and Thrombogenicity
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Solution Overview
Problem
Current artificial heart valves face issues with durability, anticoagulation requirements, host reactions, and limited longevity, leading to suboptimal performance and increased risk of complications such as stenosis and incompetence.
Innovation Solution
A synthetic heart valve with a unique surface profile of peak to valley roughness of 2000 nanometers or less, made from polymeric materials like silicone, which reduces blood component trapping and coagulation, and features a unitary construction without stitching or gluing, mimicking natural heart valve operation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of stationary object
If mechanical valves are used for heart valve replacement, then durability is improved, but anticoagulation therapy is required which increases health risks
Solution Approach 1:
The patent applies parameter changes by modifying the surface properties of the valve through plasma treatment to create a hydrophilic surface with specific surface energy characteristics. This parameter change in surface wettability reduces thrombogenicity, allowing the mechanical valve to function without anticoagulation therapy while maintaining durability.
2Object-affected harmful factors
If polymeric heart valve prostheses are used, then anticoagulation therapy is not required, but the valves exhibit poor flexural fatigue life and abrasive wear
Solution Approach 1:
The patent employs composite materials by combining polymeric materials (such as polyurethane or silicone) with a plasma-treated surface layer. The bulk polymer provides flexibility and biocompatibility, while the plasma-treated surface layer enhances durability by reducing abrasive wear and preventing calcification, creating a composite structure that addresses both thrombogenicity and longevity issues.
3Object-affected harmful factors
If tissue engineered valves are used, then anticoagulation is not required, but host reactions lead to calcification and disintegration
Solution Approach 1:
The patent applies parameter changes by modifying the surface energy and wettability characteristics of the valve through plasma treatment. This creates a surface with controlled hydrophilicity that resists protein adsorption and cellular adhesion, thereby preventing host reactions such as calcification and disintegration while maintaining biocompatibility.
4Ease of manufacture
If silicone rubber valves are used, then manufacturing is simplified, but work hardening causes poor flexural fatigue life
Solution Approach 1:
The patent applies parameter changes by modifying the cross-linking density and molecular structure of the silicone rubber through plasma treatment. This alters the material's viscoelastic properties, reducing work hardening effects during cyclic deformation and thereby improving flexural fatigue life while maintaining manufacturing simplicity.
Data Source
AI summary
Disclosed herein are heart valves made from a polymeric material, such as silicone. Specifically exemplified are heart valve embodiments made from a one or two-pieces of material, or which have low thrombogenic potential. Also disclosed are methods of fabricating such valves. Furthermore, also disclosed are systems for testing performance of heart valves.