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New polyurethane heart valve prosthesis: design, manufacture and evaluation
T G Mackay1, D J Wheatley, G M Bernacca
1Department of Cardiac Surgery, Royal Infirmary, Glasgow, UK.
Biomaterials
|October 1, 1996
Summary
A novel polyurethane tri-leaflet heart valve demonstrates promising durability and reduced leakage compared to existing options. This innovative design warrants further clinical evaluation for prosthetic heart valve applications.
Area of Science:
- Biomaterials Engineering
- Cardiovascular Devices
- Polymer Science
Background:
- Mechanical heart valves pose thrombogenicity risks, while bioprosthetic valves have limited durability.
- There is a need for advanced prosthetic heart valve materials and designs offering improved performance and longevity.
Purpose of the Study:
- To develop and evaluate a novel tri-leaflet prosthetic heart valve constructed entirely from polyurethane.
- To assess the hydrodynamic performance and durability of the new polyurethane valve design.
Main Methods:
- A single dip coating operation was used to form thin polyurethane leaflets integrated with a flexible polyurethane frame.
- Hydrodynamic tests were conducted to measure pressure gradients, regurgitation, and leakage.
- Accelerated fatigue testing was performed to evaluate valve durability, simulating long-term function.
Main Results:
- The polyurethane valve exhibited pressure gradients comparable to bioprosthetic valves.
- Regurgitation and leakage were significantly lower than those of mechanical and bioprosthetic valves.
- Six valves successfully completed 10 years of simulated function in accelerated fatigue tests, with some reaching the equivalent of 13 years.
Conclusions:
- The polyurethane tri-leaflet heart valve shows potential as an alternative to existing prosthetic valves.
- Its simple manufacturing process and favorable in vitro performance, particularly in durability and reduced leakage, justify further investigation.