Development of tests to evaluate candidate elastomers for artificial heart diaphragms.

Area of Science:

• Biomaterials Science
• Mechanical Engineering
• Medical Device Development

Background:

• Blood pump diaphragms require biocompatibility and exceptional durability for long-term flexing.
• Limited elastomer options exist, and evaluating new materials is challenging due to a lack of standardized short-term in vitro testing.
• Developing reliable in vitro methods is crucial for advancing artificial heart technology.

Purpose of the Study:

• To develop and validate an accelerated fatigue testing methodology for evaluating candidate elastomers for blood pump diaphragms.
• To establish a reliable in vitro method that predicts long-term in vivo performance.
• To facilitate the introduction and acceptance of novel or modified elastomeric materials.

Main Methods:

• Designed and constructed a 100-position fatigue testing machine for controlled environment operation.
• Utilized a previously built 30-position fatigue tester alongside the new machine.
• Generated fatigue data on 13 elastomeric materials under diverse testing conditions.

Main Results:

• The developed accelerated fatigue testing methodology successfully predicted long-term performance.
• Short-term fatigue test results demonstrated strong correlation with longer-term fatigue data.
• Data was generated on 13 elastomeric materials, providing a valuable dataset for material selection.

Conclusions:

• The accelerated fatigue testing methodology is a viable tool for assessing blood pump diaphragm elastomers.
• This method overcomes the limitations of current in vitro testing, enabling faster material evaluation.
• The findings support the use of this methodology to accelerate the development and adoption of improved artificial heart components.