The tricusp semilunar elastomeric artificial heart valve: A standardization of the manufacturing process by vacuum forming

The purpose of this project was to standardize the exact method of vacuum forming the tricusp semilunar valve made of polyurethane. The manufacturing process for this valve has evolved over the past two decades. As each new co-worker in Dr. Kolff's laboratory worked on the valve, they interjected new methods and techniques. Many of these new methods and techniques were subjectively determined and again changed when the next co-worker began manufacturing the valve. For this project the current methods and techniques of each step in the manufacturing process were evaluated. A preliminary standardization for each step was then determined and described in a written protocol. This protocol is not considered or intended to be a final description of the "best" manufacturing process. It is only a standardization that will be used as a reference for all testing and expected changes. All new and present technicians who manufacture the valve will follow the protocol. The arduous and expensive process of testing and improving the valve will be undertaken as part of a larger project (the development of an Electrohydraulic Total Artificial Heart) with an expected five year completion date. All future changes to the tricusp artificial heart valve manufacturing protocol will require satisfactory evidence that the change is necessary.